Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)

ClinicalTrials.gov ID: NCT06498661

Public ClinicalTrials.gov record NCT06498661. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:46 AM EDT

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Official title

NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06498661
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: National Cancer Institute (NCI); NIH
Enrollment: 750 participants

Conditions and interventions

Conditions

Interventions

Procedure · Other

Eligibility (public fields only)

Age range: 25 Years and older
Sex: Female
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 25, 2024
Primary completion: Dec 29, 2026
Completion: Jun 29, 2027
Last update posted: Jun 16, 2026

2024 – 2027

United States locations

U.S. sites: 14
U.S. states: 13
U.S. cities: 14

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	35233	—
University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	33136	—
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	30322	—
Louisiana State University Health Science Center	New Orleans	Louisiana	70112	—
Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	21287	—
University of New Mexico Cancer Center	Albuquerque	New Mexico	87106	—
Montefiore Medical Center-Einstein Campus	The Bronx	New York	10461	—
UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	27599	—
University of Cincinnati Cancer Center-UC Medical Center	Cincinnati	Ohio	45219	—
University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	73104	—
University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania	19104	—
UPMC-Magee Womens Hospital	Pittsburgh	Pennsylvania	15213	—
UT MD Anderson Cancer Center	Houston	Texas	77030	—
VCU Massey Comprehensive Cancer Center	Richmond	Virginia	23298	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06498661, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 16, 2026 · Synced Sep 2, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06498661 live on ClinicalTrials.gov.

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