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

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. 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.

Conditions

• Cervical Carcinoma
• Human Papillomavirus Infection

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of cervical samples by clinician

PROCEDURE

Cervical Biopsy

Undergo cervical biopsy conducted by clinician

PROCEDURE

Colposcopy

Undergo colposcopy conducted by clinician

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Endocervical Curettage

Undergo endocervical curettage conducted by clinician

PROCEDURE

Excision

Undergo cervical excisional procedure conducted by clinician

PROCEDURE

HPV Self-Collection

Undertake self-collection of vaginal samples

PROCEDURE

Human Papillomavirus Test

Undergo HPV testing of self-collected vaginal samples and cervical samples

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Vikrant V Sahasrabuddhe · National Cancer Institute Division of Cancer Prevention

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-26

Primary Completion

2026-12-30

Completion

2027-06-30

Countries

• United States
• Puerto Rico

Study Locations