HPVNCT04585243
Self-sampling for Human Papillomavirus (HPV) Among Patients Receiving Colposcopy
A study testing Evalyn Brush in people with HPV, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study seeks to compare the accuracy and acceptability of HPV testing self-sampling kit and standard clinician-sampling for HPV testing. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test, Pap smear results, and colposcopy. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- HPV
- What is being tested?
- Evalyn Brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Penn State Health Patient
- Has an intact cervix
- Found to have abnormal findings on Pap/HPV test that requires a colposcopy
- Speaks, read, or writes well in English or Spanish
Who cannot join
- Pregnant
- Cognitively impaired
- Incarcerated
- Complete hysterectomy
- History of cervical treatment for abnormal Pap/HPV test (i.e. cryotherapy, loop electrosurgical excision procedure (LEEP))
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HPV Self-sampling Among Women at the Penn State Hershey Colposcopy Clinics
This study seeks to compare the accuracy and acceptability of HPV testing self-sampling kit and standard clinician-sampling for HPV testing. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test, Pap smear results, and colposcopy. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative.
Read the detailed description
The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical cancer in 2018 (Siegel et al., 2018). Screening can reduce cancer mortality by (1) detecting malignancies when they are more treatable and (2) for some tests, identifying precancerous lesions for removal (Shieh et al., 2016). Guidelines recommend cytology and/or HPV testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal (U.S. Preventive Services Task Force, 2018; Saslow et al., 2012).
To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical-sampling for HPV testing. However, there are concerns about the comparability and acceptability of self-sampling kits.
The main objective of this study is to compare the test characteristics of the human papillomavirus (HPV) self-sampling kit versus clinician-sampled HPV testing for cervical cancer screening. Potential participants will be identified from the Penn State Family and Community Medicine and OBGYN clinics after it is determined that they have abnormal findings on their (clinician-sampled) Pap/HPV test and require a follow-up colposcopy. The patient will be pre-screened by a study team member. If they are found to be eligible, a study team member will invite them to participate in the study.
After a participant enrolls in the study, a self-sampling kit is mailed to their home along with a Summary Explanation of Research consent form and instructional sheet. Participants will be asked to complete the kit two weeks before or after their colposcopy, giving them a 28 day collection window. Study team members will perform a follow-up survey after the sample is collected and provide reminder phone calls if needed.
- Conditions
- HPV
- Being tested
- Evalyn Brush
- Keywords
- HPV, Self-Sampling, Colposcopy, Cervical cancer, Cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evalyn BrushDevice
The Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home.
| Study group | Role | What they receive |
|---|---|---|
| Self-Sampling Kit | Experimental | Participants will be mailed a Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening. Receives: Device: Evalyn Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Concordance of Screening Results of the Self-Sampling Kit Compared to Clinician-collected Samples
The primary outcome of this study is to analyze the number of participants with concordance of screening results of the self-sampling kit compared to clinician-collected HPV test, Pap smear results, and colposcopy.
Measured: Within two weeks of their colposcopy exam.
Secondary outcomes (2)
Number of Completed Self-Sampling Kits
The number of participants provided a kit vs. those who completed the sample collection
Measured: Within two weeks of their colposcopy exam.
Number of Participants Who Reported Problems Using Self-Sampling Kits
The number of participants, among those who completed the sample collection, who reported problems using the self-sampling kit.
Measured: Within two weeks of their colposcopy exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start9 Dec 2020
- Primary completion30 Sep 2022
- Study completion5 Oct 2022
Why it stopped: low recruitment, preliminary analyses indicates that primary endpoint has been met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants who enroll in the study will be asked to complete an HPV self-sampling kit in addition to completing their colposcopy exam. Participants will collect the sample at home before or after their exam and mail it back to the Penn State Health laboratory for analysis. The results will be compared to those of the clinician-collected (standard of care) colposcopy exam, Pap, and HPV test. Participants will also complete a follow up survey over the phone after their sample is collected.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer L. Moss, PhD, Milton S. Hershey Medical Center
- Investigators
- Jennifer Moss, PhD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585243
- Sponsor's protocol ID
- 13464
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2020
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
PubMed 29313949Shieh Y, Eklund M, Sawaya GF, Black WC, Kramer BS, Esserman LJ. Population-based screening for cancer: hope and hype. Nat Rev Clin Oncol. 2016 Sep;13(9):550-65. doi: 10.1038/nrclinonc.2016.50. Epub 2016 Apr 13.
PubMed 27071351U. S. Preventive Services Task Force. Final recommendation statement: Cervical cancer: Screening; 2018. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-screening2. Accessed 2018.
Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J, Garcia FA, Moriarty AT, Waxman AG, Wilbur DC, Wentzensen N, Downs LS Jr, Spitzer M, Moscicki AB, Franco EL, Stoler MH, Schiffman M, Castle PE, Myers ER; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72. doi: 10.3322/caac.21139. Epub 2012 Mar 14.
PubMed 22422631Wong A, Morgis R, Entenman J, Ramirez SI, Hays AL, Wright TS, Scartozzi CM, Ruffin MT, Moss JL. Exploratory Analysis of Concordance Between Clinician-Collected and Self-Sampled Human Papillomavirus Tests in a Small Cohort of Average- and High-Risk Patients. Womens Health Rep (New Rochelle). 2024 Mar 13;5(1):259-266. doi: 10.1089/whr.2024.0004. eCollection 2024.
PubMed 38516651
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Self-sampling Among Women at the Penn State Hershey Colposcopy Clinics
- ClinicalTrials.gov ID
- NCT04585243
- Acronym / sponsor ID
- 13464
- Conditions
- HPV
- Keywords
- HPV, Self-Sampling, Colposcopy, Cervical cancer, Cancer screening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment, preliminary analyses indicates that primary endpoint has been met
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 22 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to compare the accuracy and acceptability of HPV testing self-sampling kit and standard clinician-sampling for HPV testing. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test, Pap smear results, and colposcopy. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative.
Detailed description
The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical cancer in 2018 (Siegel et al., 2018). Screening can reduce cancer mortality by (1) detecting malignancies when they are more treatable and (2) for some tests, identifying precancerous lesions for removal (Shieh et al., 2016). Guidelines recommend cytology and/or HPV testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal (U.S. Preventive Services Task Force, 2018; Saslow et al., 2012).
To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical-sampling for HPV testing. However, there are concerns about the comparability and acceptability of self-sampling kits.
The main objective of this study is to compare the test characteristics of the human papillomavirus (HPV) self-sampling kit versus clinician-sampled HPV testing for cervical cancer screening. Potential participants will be identified from the Penn State Family and Community Medicine and OBGYN clinics after it is determined that they have abnormal findings on their (clinician-sampled) Pap/HPV test and require a follow-up colposcopy. The patient will be pre-screened by a study team member. If they are found to be eligible, a study team member will invite them to participate in the study.
After a participant enrolls in the study, a self-sampling kit is mailed to their home along with a Summary Explanation of Research consent form and instructional sheet. Participants will be asked to complete the kit two weeks before or after their colposcopy, giving them a 28 day collection window. Study team members will perform a follow-up survey after the sample is collected and provide reminder phone calls if needed.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants who enroll in the study will be asked to complete an HPV self-sampling kit in addition to completing their colposcopy exam. Participants will collect the sample at home before or after their exam and mail it back to the Penn State Health laboratory for analysis. The results will be compared to those of the clinician-collected (standard of care) colposcopy exam, Pap, and HPV test. Participants will also complete a follow up survey over the phone after their sample is collected.
| Arm | Type | Receives |
|---|---|---|
| Self-Sampling Kit | Experimental | Device: Evalyn BrushParticipants will be mailed a Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Penn State Health Patient
- Has an intact cervix
- Found to have abnormal findings on Pap/HPV test that requires a colposcopy
- Speaks, read, or writes well in English or Spanish
Key exclusion criteria (5 listed)
- Pregnant
- Cognitively impaired
- Incarcerated
- Complete hysterectomy
- History of cervical treatment for abnormal Pap/HPV test (i.e. cryotherapy, loop electrosurgical excision procedure (LEEP))
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 |
|---|---|---|
| Evalyn BrushThe Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home. | Device | Self-Sampling Kit |
Primary outcome
Number of Participants With Concordance of Screening Results of the Self-Sampling Kit Compared to Clinician-collected Samples
Time frame: Within two weeks of their colposcopy exam.
The primary outcome of this study is to analyze the number of participants with concordance of screening results of the self-sampling kit compared to clinician-collected HPV test, Pap smear results, and colposcopy.
2 secondary outcomes
Number of Completed Self-Sampling Kits
Time frame: Within two weeks of their colposcopy exam.
Number of Participants Who Reported Problems Using Self-Sampling Kits
Time frame: Within two weeks of their colposcopy exam
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29313949Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
- Background: PubMed 27071351Shieh Y, Eklund M, Sawaya GF, Black WC, Kramer BS, Esserman LJ. Population-based screening for cancer: hope and hype. Nat Rev Clin Oncol. 2016 Sep;13(9):550-65. doi: 10.1038/nrclinonc.2016.50. Epub 2016 Apr 13.
- BackgroundU. S. Preventive Services Task Force. Final recommendation statement: Cervical cancer: Screening; 2018. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-screening2. Accessed 2018.
- Background: PubMed 22422631Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J, Garcia FA, Moriarty AT, Waxman AG, Wilbur DC, Wentzensen N, Downs LS Jr, Spitzer M, Moscicki AB, Franco EL, Stoler MH, Schiffman M, Castle PE, Myers ER; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72. doi: 10.3322/caac.21139. Epub 2012 Mar 14.
- Derived from this study: PubMed 38516651Wong A, Morgis R, Entenman J, Ramirez SI, Hays AL, Wright TS, Scartozzi CM, Ruffin MT, Moss JL. Exploratory Analysis of Concordance Between Clinician-Collected and Self-Sampled Human Papillomavirus Tests in a Small Cohort of Average- and High-Risk Patients. Womens Health Rep (New Rochelle). 2024 Mar 13;5(1):259-266. doi: 10.1089/whr.2024.0004. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for HPV
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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.
Jennifer Moss, PhD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evalyn Brush in people with HPV, run by Milton S. Hershey Medical Center at 1 site in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Concordance of Screening Results of the Self-Sampling Kit Compared to Clinician-collected Samples (time frame: Within two weeks of their colposcopy exam.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585243, which also lists 5 linked publications.
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 11 Oct 2023.