Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jul 11, 2024

Keywords

ClinConnect Summary

The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is studying a new approach to cervical cancer screening. The trial is looking at whether women can collect their own vaginal samples for testing for the human papillomavirus (HPV), a virus that can lead to cervical cancer, instead of having a doctor collect the samples during a pelvic exam. This method may be more comfortable and convenient for many women, especially since many do not get screened regularly. The goal is to see if self-collected samples are as accurate as those collected by a healthcare professional.

To participate in this trial, you need to be a woman aged 25 or older who has had a referral for a colposcopy or cervical procedure due to abnormal test results. You should also be willing to provide consent for the study and be able to undergo the necessary procedures. If you decide to join, you can expect to collect your own sample for HPV testing in a way that feels more private. This trial is part of a larger effort to improve access to cervical cancer screenings and help prevent cancer before it starts.

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 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