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Active, not recruiting Not applicable Interventional Accepts healthy volunteers

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.

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

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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
Enrollment
750 participants

Conditions and interventions

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

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Open the official record

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

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