Self-collection of vaginal samples for HPV testing to enhance cervical cancer prevention
NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01
This study tests if women can accurately collect their own vaginal samples for HPV testing to help find cervical cancer earlier, compared to samples taken by a doctor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | National Cancer Institute (NCI) NIH |
| Locations | 25 sites (Birmingham, Alabama and 24 other locations) |
| Trial ID | NCT06498661 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of self-collected vaginal samples for HPV testing in patients referred for colposcopy and cervical procedures. The study aims to determine the clinical accuracy of self-collected samples compared to clinician-collected samples in detecting cervical precancer and cancer. Participants will provide two self-collected samples and undergo standard care procedures, including colposcopy and potential biopsies. The trial also explores factors affecting the usability and acceptability of self-collection methods.
Who should consider this trial
Good fit: Ideal candidates are women aged 25 and older who have been referred for colposcopy or cervical excisional procedures and have had recent HPV testing.
Not a fit: Patients who are pregnant or have had recent cervical treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could increase cervical cancer screening rates and early detection, ultimately reducing cervical cancer incidence.
How similar studies have performed: Other studies have shown promise in using self-collection methods for HPV testing, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willingness and ability to provide a documented informed consent * Is 25 years or older * Has an intact cervix * Has had a referral for colposcopy and/or cervical excisional procedure in which routine cervical cancer screening has included 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 * 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 Exclusion Criteria: * Is pregnant when presenting for the referral visit or gave birth within the past 3 months * 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 * Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records * Known medical conditions that, in the opinion of the investigator, preclude study participation * Previous participation in the SHIP trial. Participation is defined as completing the self-collection * Is experiencing unusual bleeding or pelvic pain
Where this trial is running
Birmingham, Alabama and 24 other locations
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (Recruiting)
- UCSF Medical Center-Parnassus — San Francisco, California, United States (Not_yet_recruiting)
- Yale University — New Haven, Connecticut, United States (Not_yet_recruiting)
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (Recruiting)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- UofL Health Medical Center Northeast — Louisville, Kentucky, United States (Not_yet_recruiting)
- Louisiana State University Health Science Center — New Orleans, Louisiana, United States (Recruiting)
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States (Recruiting)
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States (Not_yet_recruiting)
- Minneapolis VA Medical Center — Minneapolis, Minnesota, United States (Not_yet_recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Not_yet_recruiting)
- University of New Mexico Cancer Center — Albuquerque, New Mexico, United States (Not_yet_recruiting)
- Montefiore Medical Center-Einstein Campus — Bronx, New York, United States (Recruiting)
- NYP/Weill Cornell Medical Center — New York, New York, United States (Not_yet_recruiting)
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
- University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Not_yet_recruiting)
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
- University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- UPMC-Magee Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States (Not_yet_recruiting)
- Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States (Recruiting)
- University of Washington Medical Center - Northwest — Seattle, Washington, United States (Not_yet_recruiting)
- University of Puerto Rico — San Juan, Puerto Rico (Recruiting)
Study contacts
- Principal investigator: Vikrant V Sahasrabuddhe — National Cancer Institute Division of Cancer Prevention
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.