Actively Recruiting
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
500
Participants Needed
18
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. HPV is known to cause a variety of cancers including cervical cancer. Even though there are ways to detect cervical cancer, many individuals are not diagnosed. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. The low screening numbers show more testing needs to be done. Without appropriate screening and care, preventable precancer may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own 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. Information gathered from 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.
CONDITIONS
Official Title
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness and ability to provide a documented informed consent
- Is 25 years or older
- Has an intact cervix
- Has had a referral for colposcopy with positive HPV testing or abnormal cytology within the past 12 months, and/or for cervical excisional procedure
- Willing and able to undergo colposcopy and, if needed, biopsy, endocervical curettage, and/or cervical excisional procedure
You will not qualify if you...
- 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 in the last 12 months prior to the referral visit
- Has had a complete or partial hysterectomy, including removal of the cervix
- Known medical conditions that prevent study participation as judged by the investigator
- Previous participation in this trial or another cervical cancer screening study within the past 12 months
- Is experiencing unusual bleeding or pelvic pain
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Trial Site Locations
Total: 18 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Louisiana State University
Lafayette, Louisiana, United States, 70503
Actively Recruiting
4
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
5
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
6
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
7
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
8
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States, 10461
Actively Recruiting
9
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
10
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
11
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
12
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73190
Actively Recruiting
13
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
15
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
16
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
18
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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