Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)

Launched by NATIONAL CANCER INSTITUTE (NCI) · Sep 24, 2024

Keywords

ClinConnect Summary

The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is looking at a new way for women to get tested for HPV, a virus that can lead to cervical cancer. Instead of having a doctor collect samples during a pelvic exam, this trial allows women to collect their own vaginal samples at home. This approach aims to make screening more comfortable and accessible, especially for those who may not have had regular screenings in the past. The study will compare the accuracy of these self-collected samples to those taken by a clinician to see if this method can help prevent cervical cancer more effectively.

To participate in the trial, women need to be at least 25 years old, have an intact cervix, and have been referred for a colposcopy (a procedure to closely examine the cervix) with recent routine HPV testing. Participants should be willing to provide consent and be able to undergo the necessary procedures. However, pregnant women, those who have recently given birth, or individuals with certain medical conditions are not eligible. If you join this trial, you can expect to learn more about your risk for cervical cancer through this innovative self-collection method, helping to improve cervical cancer prevention for everyone.

Gender

FEMALE

Eligibility 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 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 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