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

Running, not enrolling · Not applicable

Conditions studied: Cervical Carcinoma, Human Papillomavirus Infection

In brief

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 cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.

Key facts

Study ID

NCT06611553

Run by

National Cancer Institute (NCI)

People needed

500

Starts

2024-09-13

Expected to finish

2027-06-30

Last updated by the study team

2026-07-07

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• Louisiana State University Health Science Center — New Orleans, Louisiana, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• NYP/Weill Cornell Medical Center — New York, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• UPMC-Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
• University of Puerto Rico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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