Human Papillomavirus-Related Cervical CarcinomaNCT06607874
Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention Among Women in Emergency Care in Northeast Florida
An observational study of Human Papillomavirus-Related Cervical Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
Human Papilloma Virus (HPV) is a cause of cervical cancer in women. This study is being done to identify sites for cervical cancer screening and education regarding HPV vaccination outside of the traditional settings of primary care and gynecologic clinics. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus-Related Cervical Carcinoma
- What is being tested?
- Non-Interventional Study
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2027to 16 Oct 2028
- Phase
- Observational
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients recruited after previous ED visits
Who may be able to join
- Adults assigned as female at birth age 18-65 with a Mayo Clinic medical record number
Who cannot join
- Adults assigned as female at birth age 0-17
- Adults assigned as female at birth age > 65
- Adults assigned as male at birth
- Adults assigned as female at birth without a Mayo Clinic medical record number
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Caroline Chang, 904-953-4637, Chang.Caroline@mayo.edu
About this study
Official title: Eligibility and Participation Characteristics of a Pilot Study of Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention
Human Papilloma Virus (HPV) is a cause of cervical cancer in women. This study is being done to identify sites for cervical cancer screening and education regarding HPV vaccination outside of the traditional settings of primary care and gynecologic clinics. Identifying non-traditional cancer screening settings may increase cancer screening completion and HPV vaccination among women with limited health care knowledge and access who are vulnerable to health disparities.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational aim 1 & aim 3 | Patients may choose to undergo HPV vaginal swab self-collection on study in the research clinic or at home. Patients may choose to complete an interview on study. In addition, patients have their medical records reviewed on study. Receives: Other: Non-Interventional Study | |
| Observational aim 2 | Patients are contacted by the study Clinical Research Coordinator (CRC) by phone on study and informed of HPV vaccination eligibility, asked interest in being vaccinated, and informed of sites for HPV vaccination. Patients are then contacted again by the CRC to determine if HPV vaccination occurred. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation
Will be assessed by the percentage of women between 25-65 eligible for cervical cancer screening who participate or who opt not to participate in self-collection.
Measured: Baseline
HPV vaccination following ED presentation
Will be assessed by the percentage of women between 18-26 eligible for HPV vaccination for cervical cancer prevention who participate in HPV vaccination. Participants will be contacted one month after initial contact to determine if the HPV vaccination was administered.
Measured: One month
Interviews of women who decline self-collection
Phone or video-based interviews will be conducted with eligible participants who decline self-collection to determine reasons for non-participation.
Measured: Baseline
Interviews of women who consent to self-collection but do not complete the self-collection
Phone or video-based interviews will be conducted with participants who agree to participate but do not complete self-collection after 4 weeks to determine reasons for non-participation.
Measured: Up to 6 weeks
Interviews of women who complete the self-collection
Phone or video-based interviews will be conducted with participants who completed self-collection for feedback on the process.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start16 Sep 2027 (estimated)
- Primary completion16 Oct 2028 (estimated)
- Study completion16 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus-Related Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher C. DeStephano, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607874
- Sponsor's protocol ID
- 23-009193
- Other IDs
- NCI-2024-07532, 23-009193
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eligibility and Participation Characteristics of a Pilot Study of Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention
- ClinicalTrials.gov ID
- NCT06607874
- Acronym / sponsor ID
- 23-009193
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Sep 2027 (estimated)
- Primary completion
- 16 Oct 2028 (estimated)
- Study completion
- 16 Oct 2028 (estimated)
- First posted
- 23 Sep 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.
Human Papilloma Virus (HPV) is a cause of cervical cancer in women. This study is being done to identify sites for cervical cancer screening and education regarding HPV vaccination outside of the traditional settings of primary care and gynecologic clinics. Identifying non-traditional cancer screening settings may increase cancer screening completion and HPV vaccination among women with limited health care knowledge and access who are vulnerable to health disparities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational aim 1 & aim 3 | – | Other: Non-Interventional StudyPatients may choose to undergo HPV vaginal swab self-collection on study in the research clinic or at home. Patients may choose to complete an interview on study. In addition, patients have their medical records reviewed on study. |
| Observational aim 2 | – | Other: Non-Interventional StudyPatients are contacted by the study Clinical Research Coordinator (CRC) by phone on study and informed of HPV vaccination eligibility, asked interest in being vaccinated, and informed of sites for HPV vaccination. Patients are then contacted again by the CRC to determine if HPV vaccination occurred. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients recruited after previous ED visits
Key inclusion criteria (1 listed)
- Adults assigned as female at birth age 18-65 with a Mayo Clinic medical record number
Key exclusion criteria (4 listed)
- Adults assigned as female at birth age 0-17
- Adults assigned as female at birth age > 65
- Adults assigned as male at birth
- Adults assigned as female at birth without a Mayo Clinic medical record number
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 |
|---|---|---|
| Non-Interventional StudyNon-Interventional study | Other | Observational aim 1 & aim 3, Observational aim 2 |
Primary outcome
Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation
Time frame: Baseline
Will be assessed by the percentage of women between 25-65 eligible for cervical cancer screening who participate or who opt not to participate in self-collection.
HPV vaccination following ED presentation
Time frame: One month
Will be assessed by the percentage of women between 18-26 eligible for HPV vaccination for cervical cancer prevention who participate in HPV vaccination. Participants will be contacted one month after initial contact to determine if the HPV vaccination was administered.
Interviews of women who decline self-collection
Time frame: Baseline
Phone or video-based interviews will be conducted with eligible participants who decline self-collection to determine reasons for non-participation.
Interviews of women who consent to self-collection but do not complete the self-collection
Time frame: Up to 6 weeks
Phone or video-based interviews will be conducted with participants who agree to participate but do not complete self-collection after 4 weeks to determine reasons for non-participation.
Interviews of women who complete the self-collection
Time frame: Up to 6 weeks
Phone or video-based interviews will be conducted with participants who completed self-collection for feedback on the process.
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 5 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Human Papillomavirus-Related Cervical Carcinoma
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Cervical Cancer, Throat Cancer
Active, not recruitingPhase 4
Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial
Human Papillomavirus-Related Cervical Carcinoma
Active, not recruitingPhase 1/2
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Carcinoma
RecruitingPhase 2
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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.
Christopher C. DeStephano, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus-Related Cervical Carcinoma, run by Mayo Clinic 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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Aug 2026. 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?
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?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation (time frame: Baseline). The study lists 5 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 5 Aug 2026.