Status:
ACTIVE_NOT_RECRUITING
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cervical Carcinoma
Human Papillomavirus Infection
Eligibility:
FEMALE
25+ years
Phase:
NA
Brief 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 ce...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cance...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06611540
Start Date
September 11 2024
End Date
December 31 2026
Last Update
December 30 2025
Active Locations (11)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
UofL Health Medical Center Northeast
Louisville, Kentucky, United States, 40245
3
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
4
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417