Status:
ACTIVE_NOT_RECRUITING
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)
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 OBJECTIVE: I. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer...
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 cell 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 standard of care (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 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06611553
Start Date
September 13 2024
End Date
December 31 2026
Last Update
December 15 2025
Active Locations (14)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Yale University
New Haven, Connecticut, United States, 06520
3
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
4
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112