NCT06611553

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

Active, enrolled NA Last updated 15 December 2025

What this trial tests

NA trial testing Biospecimen Collection in Cervical Carcinoma in 500 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 September 2024

Primary endpoint
30 June 2026

31 December 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	500
Start date	13 September 2024
Primary completion	30 June 2026
Estimated completion	31 December 2026
Sites	14 locations across Puerto Rico, United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Cervical Biopsy — full drug profile →
• Colposcopy
• Electronic Health Record Review
• Endocervical Curettage
• Excision
• HPV Self-Collection
• Human Papillomavirus Test
• Questionnaire Administration
• Survey Administration

Conditions studied

• Cervical Carcinoma — all drugs for Cervical Carcinoma →
• Human Papillomavirus Infection — all drugs for Human Papillomavirus Infection →

Sponsor

National Cancer Institute (NCI)

Who can join

25 and older, female only, with Cervical Carcinoma or Human Papillomavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.