Cervical CarcinomaSHIP-A-S01NCT06498661
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)
A study testing Biospecimen Collection, Cervical Biopsy and Colposcopy in people with Cervical Carcinoma and Human Papillomavirus Infection, run by National Cancer Institute (NCI) at 15 sites in 2 countries.
Trial summary
This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Carcinoma, Human Papillomavirus Infection
- What is being tested?
- Biospecimen Collection, Cervical Biopsy and Colposcopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 26 Jun 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- GROUP A: Willingness and ability to provide a documented informed consent
- GROUP A: Is 25 years or older
- GROUP A: Has an intact cervix
- GROUP A: Has had a referral for colposcopy or cervical excisional procedure in which routine cervical cancer screening has included positive HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance [ASC-US] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit
- GROUP A: Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable
- GROUP B: Willingness and ability to provide a documented informed consent
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- GROUP B: Is 25 years or older
- GROUP B: Has an intact cervix
- GROUP B: Eligible for regular cervical cancer screening by current national guidelines
Who cannot join
- GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months
- GROUP A: Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure [LEEP], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit
- GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation
- GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
- GROUP A: Is experiencing unusual bleeding or pelvic pain
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- GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months
- GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit
- GROUP B: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation
- GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
- GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain
- GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
UT MD Anderson Cancer Center
Houston, Texas, 77030
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
About this study
Official title: NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01
This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician.
The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician collected (CC) samples for the following HPV genotype detections and groupings by Becton, Dickinson and Company (BD) Onclarity (trademark) HPV assay: Any high risk (HR) HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group A) II. To conduct an observational study among women attending regular cervical cancer screening ("intended use population" for the at-home collection indication). (Group B)
EXPLORATORY OBJECTIVES:
- To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group A) II. To evaluate agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC samples for the following HPV genotype detections and groupings by BD Onclarity™ HPV assay: Any HR HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group B) III. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group B)
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
GROUP B: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
After completion of study intervention (one time), laboratory results available within 30 days are collected for study analysis purposes.
- Conditions
- Cervical Carcinoma, Human Papillomavirus Infection
- Being tested
- Biospecimen Collection, Cervical Biopsy, Colposcopy, Electronic Health Record Review, Endocervical Curettage
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of cervical samples by clinician
Cervical BiopsyProcedure or surgery
Undergo cervical biopsy conducted by clinician
ColposcopyProcedure or surgery
Also called CP
Undergo colposcopy conducted by clinician
Electronic Health Record ReviewOther
Ancillary studies
Endocervical CurettageProcedure or surgery
Undergo endocervical curettage conducted by clinician
ExcisionProcedure or surgery
Also called Abscission, Extirpation, Surgical Removal
Undergo cervical excisional procedure conducted by clinician
HPV Self-CollectionProcedure or surgery
Also called At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection
Undertake self-collection of vaginal samples
Human Papillomavirus TestProcedure or surgery
Also called HPV Assay, HPV Test, Human Papillomavirus
Undergo HPV testing of self-collected vaginal samples and cervical samples
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group A (self-collected and clinician-collected samples) | Experimental | Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Receives: Procedure: Biospecimen Collection; Procedure: Cervical Biopsy; Procedure: Colposcopy; Other: Electronic Health Record Review; Procedure: Endocervical Curettage; Procedure: Excision; Procedure: HPV Self-Collection; Procedure: Human Papillomavirus Test; Other: Questionnaire Administration; Other: Survey Administration |
| Group B (self-collected and clinician-collected samples) | Experimental | Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Receives: Procedure: Biospecimen Collection; Procedure: Cervical Biopsy; Procedure: Colposcopy; Other: Electronic Health Record Review; Procedure: Endocervical Curettage; Procedure: Excision; Procedure: HPV Self-Collection; Procedure: Human Papillomavirus Test; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sensitivity for self-collected (SC) samples (Group A)
Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given disease positive (e.g., cervical intraepithelial neoplasia [CIN]2+). Will report point estimate and 95% confidence intervals (CIs).
Measured: One-time, up to 30 days
Clinical sensitivity for clinician-collected (CC) samples (Group A)
Will be defined as the probability of testing HPV positive on CC sample given disease positive (e.g., CIN2+). Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Sensitivity ratio for SC versus CC samples (Group A)
Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Difference in clinical sensitivity between SC and CC samples (Group A)
Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Clinical specificity for SC samples (Group A)
Will be defined as the probability of testing HPV negative on SC sample given disease negative (e.g., < CIN2). Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Clinical specificity for CC samples (Group A)
Will be defined as the probability of testing HPV negative on CC sample given disease negative (e.g., < CIN2). Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Specificity ratio for SC versus CC samples (Group A)
Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Difference in clinical specificity between SC and CC samples (Group A)
Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
False positive rate (FPR) for SC samples (Group A)
Will be defined as the probability of testing HPV positive on SC sample given < CIN2. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
FPR for CC samples (Group A)
Will be defined as the probability of testing HPV positive on CC sample given < CIN2. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
FPR ratio for SC versus CC samples (Group A)
The FPR ratio is the FPR of SC divided by the FP of CC. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Difference in FPR ratio between SC and CC samples (Group A)
Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
False negative rate (FNR) for SC samples (Group A)
Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
FNR for CC samples (Group A)
Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
FNR ratio for SC versus CC samples (Group A)
The FNR ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Difference in FNR ratio between SC and CC samples (Group A)
Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Positive percent agreement (Group A)
Will be defined as the probability of positive on SC given positive on CC, expressed as a percent. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Negative percent agreement (Group A)
Will be defined as the probability of negative on SC given negative on CC, expressed as a percent. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Positive percent agreement (Group A and Group B)
Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Negative percent agreement (Group A and Group B)
Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Cohen's Kappa (Group A and Group B)
Will be described as a measure of agreement beyond chance between SC and CC samples, and values will be interpreted as follows: 0.00-0.19 as poor, 0.20-0.39 as fair, 0.40-0.59 as moderate, 0.60-0.79 as good, and 0.80-1.00 as excellent agreement beyond chance. Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Test positivity rates (Group A and Group B)
Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Rate of invalid test results (Group A and Group B)
Will report point estimate and 95% CIs.
Measured: One-time, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start26 Jun 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Vikrant V Sahasrabuddhe, Principal investigator, National Cancer Institute Division of Cancer Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498661
- Sponsor's protocol ID
- NCI-2024-05879
- Other IDs
- NCI-2024-05879, LMI-001-A-S01, LMI-001-A-S01
- Acronym
- SHIP-A-S01
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01
- ClinicalTrials.gov ID
- NCT06498661
- Acronym / sponsor ID
- SHIP-A-S01 / NCI-2024-05879
- Conditions
- Cervical Carcinoma, Human Papillomavirus Infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician.
The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician collected (CC) samples for the following HPV genotype detections and groupings by Becton, Dickinson and Company (BD) Onclarity (trademark) HPV assay: Any high risk (HR) HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group A) II. To conduct an observational study among women attending regular cervical cancer screening ("intended use population" for the at-home collection indication). (Group B)
EXPLORATORY OBJECTIVES:
- To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group A) II. To evaluate agreement/concordance (including positive percent agreement and negative percent agreement) on SC versus CC samples for the following HPV genotype detections and groupings by BD Onclarity™ HPV assay: Any HR HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66, HPV16 and/or HPV18, other 12 HR-HPV types (grouped). (Group B) III. To evaluate human factors affecting usability, acceptability, and preferences for self-collection. (Group B)
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
GROUP B: Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
After completion of study intervention (one time), laboratory results available within 30 days are collected for study analysis purposes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (self-collected and clinician-collected samples) | Experimental | Procedure: Biospecimen Collection, Procedure: Cervical Biopsy, Procedure: Colposcopy, Other: Electronic Health Record Review, Procedure: Endocervical Curettage, Procedure: Excision, Procedure: HPV Self-Collection, Procedure: Human Papillomavirus Test, Other: Questionnaire Administration, Other: Survey AdministrationPatients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. |
| Group B (self-collected and clinician-collected samples) | Experimental | Procedure: Biospecimen Collection, Procedure: Cervical Biopsy, Procedure: Colposcopy, Other: Electronic Health Record Review, Procedure: Endocervical Curettage, Procedure: Excision, Procedure: HPV Self-Collection, Procedure: Human Papillomavirus Test, Other: Questionnaire Administration, Other: Survey AdministrationPatients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- GROUP A: Willingness and ability to provide a documented informed consent
- GROUP A: Is 25 years or older
- GROUP A: Has an intact cervix
- GROUP A: Has had a referral for colposcopy or cervical excisional procedure in which routine cervical cancer screening has included positive HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance [ASC-US] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit
- GROUP A: Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable
Key exclusion criteria (13 listed)
- GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months
- GROUP A: Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure [LEEP], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit
- GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation
- GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of cervical samples by clinician | Procedure or surgery | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
| Cervical BiopsyUndergo cervical biopsy conducted by clinician | Procedure or surgery | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
| ColposcopyAlso: CPUndergo colposcopy conducted by clinician | Procedure or surgery | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
| Electronic Health Record ReviewAncillary studies | Other | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
| Endocervical CurettageUndergo endocervical curettage conducted by clinician | Procedure or surgery | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
| ExcisionAlso: Abscission, Extirpation, Surgical RemovalUndergo cervical excisional procedure conducted by clinician | Procedure or surgery | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
| HPV Self-CollectionAlso: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-CollectionUndertake self-collection of vaginal samples | Procedure or surgery | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
| Human Papillomavirus TestAlso: HPV Assay, HPV Test, Human PapillomavirusUndergo HPV testing of self-collected vaginal samples and cervical samples | Procedure or surgery | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
| Questionnaire AdministrationAncillary studies | Other | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
| Survey AdministrationAncillary studies | Other | Group A (self-collected and clinician-collected samples), Group B (self-collected and clinician-collected samples) |
Primary outcome
Clinical sensitivity for self-collected (SC) samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given disease positive (e.g., cervical intraepithelial neoplasia [CIN]2+). Will report point estimate and 95% confidence intervals (CIs).
Clinical sensitivity for clinician-collected (CC) samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of testing HPV positive on CC sample given disease positive (e.g., CIN2+). Will report point estimate and 95% CIs.
Sensitivity ratio for SC versus CC samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
Difference in clinical sensitivity between SC and CC samples (Group A)
Time frame: One-time, up to 30 days
Will report point estimate and 95% CIs.
Clinical specificity for SC samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of testing HPV negative on SC sample given disease negative (e.g., < CIN2). Will report point estimate and 95% CIs.
Clinical specificity for CC samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of testing HPV negative on CC sample given disease negative (e.g., < CIN2). Will report point estimate and 95% CIs.
Specificity ratio for SC versus CC samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
Difference in clinical specificity between SC and CC samples (Group A)
Time frame: One-time, up to 30 days
Will report point estimate and 95% CIs.
False positive rate (FPR) for SC samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of testing HPV positive on SC sample given < CIN2. Will report point estimate and 95% CIs.
FPR for CC samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of testing HPV positive on CC sample given < CIN2. Will report point estimate and 95% CIs.
FPR ratio for SC versus CC samples (Group A)
Time frame: One-time, up to 30 days
The FPR ratio is the FPR of SC divided by the FP of CC. Will report point estimate and 95% CIs.
Difference in FPR ratio between SC and CC samples (Group A)
Time frame: One-time, up to 30 days
Will report point estimate and 95% CIs.
False negative rate (FNR) for SC samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs.
FNR for CC samples (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs.
FNR ratio for SC versus CC samples (Group A)
Time frame: One-time, up to 30 days
The FNR ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs.
Difference in FNR ratio between SC and CC samples (Group A)
Time frame: One-time, up to 30 days
Will report point estimate and 95% CIs.
Positive percent agreement (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of positive on SC given positive on CC, expressed as a percent. Will report point estimate and 95% CIs.
Negative percent agreement (Group A)
Time frame: One-time, up to 30 days
Will be defined as the probability of negative on SC given negative on CC, expressed as a percent. Will report point estimate and 95% CIs.
Positive percent agreement (Group A and Group B)
Time frame: One-time, up to 30 days
Will report point estimate and 95% CIs.
Negative percent agreement (Group A and Group B)
Time frame: One-time, up to 30 days
Will report point estimate and 95% CIs.
Cohen's Kappa (Group A and Group B)
Time frame: One-time, up to 30 days
Will be described as a measure of agreement beyond chance between SC and CC samples, and values will be interpreted as follows: 0.00-0.19 as poor, 0.20-0.39 as fair, 0.40-0.59 as moderate, 0.60-0.79 as good, and 0.80-1.00 as excellent agreement beyond chance. Will report point estimate and 95% CIs.
Test positivity rates (Group A and Group B)
Time frame: One-time, up to 30 days
Will report point estimate and 95% CIs.
Rate of invalid test results (Group A and Group B)
Time frame: One-time, up to 30 days
Will report point estimate and 95% CIs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikrant V Sahasrabuddhe principal investigator
National Cancer Institute Division of Cancer Prevention
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Cervical Biopsy and Colposcopy in people with Cervical Carcinoma and Human Papillomavirus Infection, run by National Cancer Institute (NCI) at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical sensitivity for self-collected (SC) samples (Group A) (time frame: One-time, up to 30 days). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.