NCI Cervical Cancer 'Last Mile' Initiative 'Self-collection for HPV Testing to Improve Cervical Cancer Prevention

Launched by M.D. ANDERSON CANCER CENTER · Nov 5, 2024

Keywords

ClinConnect Summary

The NCI Cervical Cancer 'Last Mile' Initiative is a clinical trial designed to find out if samples collected by women themselves for HPV (Human Papillomavirus) testing give similar results to samples collected by doctors during regular check-ups. This study aims to improve how we prevent cervical cancer by making it easier for women to get tested for HPV, which is linked to cervical cancer.

To participate in this trial, women must be at least 25 years old, have an intact cervix, and have been referred for further cervical examinations due to previous abnormal test results. They should also be willing to undergo a procedure called colposcopy, which helps doctors look closely at the cervix. However, women who are pregnant, have recently given birth, or have had certain cervical treatments in the past year cannot take part in the study. Participants can expect to provide a sample for testing and may also undergo additional examinations if needed. This trial is still in the planning stage and is not yet recruiting participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Willingness and ability to provide a documented informed consent.
• • Is 25 years of older.
• • Has an intact cervix.
• • Has had a referral for colposcpoy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screeing, co-testing, or 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 cervical excisional procedure, as applicable.
• • Exclusion Criteria
• An individiual meeting the following criteria will be ineligible for participation in the study:
• • Is pregnant when presenting for the referal visit or gave birth within the past three months.
• • Has known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherpay, 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, prelude study participation.
• • Previous participation in the SHIP Trial. Participation is defined as completing the self-collection.