Search / Trial NCT06611553

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

Trial Information

Current as of December 30, 2024

Recruiting

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

Trial Officials

Vikrant V Sahasrabuddhe

Principal Investigator

National Cancer Institute Division of Cancer Prevention

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

New Haven, Connecticut, United States

Cleveland, Ohio, United States

Oklahoma City, Oklahoma, United States

Ann Arbor, Michigan, United States

Jackson, Mississippi, United States

Houston, Texas, United States

Salt Lake City, Utah, United States

Birmingham, Alabama, United States

Atlanta, Georgia, United States

Baltimore, Maryland, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Philadelphia, Pennsylvania, United States

Bronx, New York, United States

New Orleans, Louisiana, United States

Miami, Florida, United States

Richmond, Virginia, United States

San Francisco, California, United States

Minneapolis, Minnesota, United States

Cincinnati, Ohio, United States

Pittsburgh, Pennsylvania, United States

Albuquerque, New Mexico, United States

San Juan, , Puerto Rico

Seattle, Washington, United States

Louisville, Kentucky, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0