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Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)

NCT ID: NCT07281430

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2026-12-31

Brief Summary

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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 requirements.

Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate clinical accuracy (including clinical sensitivity, clinical specificity, false positive rate, and false negative rate) for the detection of cervical precancer/cancer and agreement/concordance (including positive percent agreement and negative percent agreement) on self-collected (SC) versus clinician-collected (CC) samples for the following HPV genotype detections and groupings by Abbott Alinity m high risk (HR) HPV assay:

Ia. Any HR HPV genotype; Ib. HPV16; Ic. HPV16 and/or HPV18; Id. Non-HPV16 high-risk HPV types (HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68); Ie. Non-HPV16/HPV18 high-risk types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

EXPLORATORY OBJECTIVE:

I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection.

OUTLINE:

Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care (SOC) colposcopy with or without cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

After completion of study intervention (one-time), laboratory results available within 60 days are collected for purposes of study outcomes.

Conditions

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Cervical Carcinoma Human Papillomavirus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

The self-collected samples and clinician collected sample have different visual appearances and content. Therefore, by design, the study will have no blinding for participants and study staff. However, a unique study sample label schema will be utilized for both sample types when tested that will not permit linkages or identification of sample pairs thereby permitting unbiased testing and reporting.

Study Groups

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Prevention (self-collected and clinician-collected samples)

Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo SOC colposcopy with or without cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of a cervical sample by clinician

Cervical Biopsy

Intervention Type PROCEDURE

Undergo cervical biopsy

Colposcopy

Intervention Type PROCEDURE

Undergo colposcopy

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Endocervical Curettage

Intervention Type PROCEDURE

Undergo endocervical curettage

Excision

Intervention Type PROCEDURE

Undergo cervical excisional procedure

HPV Self-Collection

Intervention Type PROCEDURE

Undertake self-collection of vaginal sample

Human Papillomavirus Test

Intervention Type PROCEDURE

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

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo collection of a cervical sample by clinician

Intervention Type PROCEDURE

Cervical Biopsy

Undergo cervical biopsy

Intervention Type PROCEDURE

Colposcopy

Undergo colposcopy

Intervention Type PROCEDURE

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Endocervical Curettage

Undergo endocervical curettage

Intervention Type PROCEDURE

Excision

Undergo cervical excisional procedure

Intervention Type PROCEDURE

HPV Self-Collection

Undertake self-collection of vaginal sample

Intervention Type PROCEDURE

Human Papillomavirus Test

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

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection CP Abscission Extirpation Surgical Removal At-home HPV Self Collection HPV Self Collection Human Papillomavirus Self-Collection HPV Assay HPV Test Human Papillomavirus

Eligibility Criteria

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Inclusion Criteria

* Willingness and ability to provide a documented informed consent
* Is 25 years or older
* Has an intact cervix
* Has had a referral for colposcopy in which routine cervical cancer screening has included positive HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance \[ASC-US\] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit, and/or for cervical excisional procedure
* Willing and able to undergo colposcopy, and if clinically indicated for SOC purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable

Exclusion Criteria

* Is pregnant when presenting for the referral visit or gave birth within the past 3 months
* Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \[LEEP\], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit
* Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
* Known medical conditions that, in the opinion of the investigator, preclude study participation
* Previous participation in the SHIP Trial or another cervical cancer screening study within the past 12 months. Participation is defined as completing the self-collection
* Is experiencing unusual bleeding or pelvic pain
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikrant V Sahasrabuddhe

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute Division of Cancer Prevention

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status RECRUITING

Louisiana State University

Lafayette, Louisiana, United States

Site Status RECRUITING

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status RECRUITING

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States

Site Status RECRUITING

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Warner K. Huh

Role: primary

Michael E. Hagensee

Role: primary

Elisheva Danan

Role: primary

Cosette M. Wheeler

Role: primary

Mark H. Einstein

Role: primary

Leeya F. Pinder

Role: primary

Jacqueline A. Bohn

Role: primary

Carmen Guerra

Role: primary

Harold C. Wiesenfeld

Role: primary

Elizabeth Y. Chiao

Role: primary

Deanna L. Kepka

Role: primary

Other Identifiers

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NCI-2025-09192

Identifier Type: REGISTRY

Identifier Source: secondary_id

LMI-001-A-S04

Identifier Type: OTHER

Identifier Source: secondary_id

LMI-001-A-S04

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2025-09192

Identifier Type: -

Identifier Source: org_study_id