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Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)
NCT07281430 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Electronic Health Record Review
- PROCEDURE Cervical Biopsy
- PROCEDURE Colposcopy
- PROCEDURE Endocervical Curettage
Study Locations (18)
Pennsylvania
- University of Pennsylvania/Abramson Cancer Center — Philadelphia
- UPMC-Magee Womens Hospital — Pittsburgh
- University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh
Louisiana
- Louisiana State University — Lafayette
- Louisiana State University Health Science Center — New Orleans
New York
- Montefiore Medical Center-Einstein Campus — The Bronx
- Montefiore Medical Center-Weiler Hospital — The Bronx
Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City
- University of Oklahoma — Oklahoma City
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta
Minnesota
- Minneapolis VA Medical Center — Minneapolis
New Mexico
- University of New Mexico Cancer Center — Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-11-24 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07281430
The ClinicalTrials.gov registry entry for NCT07281430 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cervical Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07281430 reports 18 study locations spanning 13 distinct geographic areas — top geographies include Pennsylvania, Louisiana, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07281430 about?
NCT07281430 is a clinical study titled "Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)". 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...
What is the current status of trial NCT07281430?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2025-11-24. Estimated completion is 2026-12-31.
What conditions does trial NCT07281430 study?
This clinical trial studies the following conditions: Cervical Carcinoma, Human Papillomavirus Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07281430?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Electronic Health Record Review (OTHER), Cervical Biopsy (PROCEDURE), Colposcopy (PROCEDURE), Endocervical Curettage (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07281430?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07281430 being conducted?
This trial has 18 study locations across Alabama, Georgia, Louisiana, Minnesota, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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