Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)

NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S03

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Carcinoma; Human Papillomavirus Infection
• Intervention / Treatment: Other: Questionnaire Administration; Other: Electronic Health Record Review; Procedure: Colposcopy; Procedure: Human Papillomavirus Test; Procedure: HPV Self-Collection; Procedure: Biospecimen Collection; Procedure: Cervical Biopsy; Procedure: Endocervical Curettage; Procedure: Excision

Detailed Description

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 the Roche cobas HPV tests:

Ia. Any high-risk (HR) HPV genotype; Ib. HPV16; Ic. HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (combined).

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 cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

After completion of study intervention (one-time), laboratory results available within 90 days are collected for purposes of study outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40245
      • UofL Health Medical Center Northeast
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Cancer Center
  • New York
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center-Einstein Campus
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Comprehensive Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Cancer Center-UC Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania/Abramson Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute/University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 and/or cervical excisional procedure in which routine cervical cancer screening has included 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.
• 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. Participation is defined as completing the self-collection.
• Is experiencing unusual bleeding or pelvic pain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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 cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

Other: Questionnaire Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Procedure: Colposcopy; Undergo colposcopy; Other Names: CP; Procedure: Human Papillomavirus Test; Undergo HPV testing of self-collected vaginal samples and cervical samples; Other Names: HPV Assay; HPV Test; Human Papillomavirus; Procedure: HPV Self-Collection; Undertake self-collection of vaginal sample; Other Names: At-home HPV Self Collection; HPV Self Collection; Human Papillomavirus Self-Collection; Procedure: Biospecimen Collection; Undergo collection of a cervical sample by clinician; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection; Procedure: Cervical Biopsy; Undergo cervical biopsy; Procedure: Endocervical Curettage; Undergo endocervical curettage; Procedure: Excision; Undergo cervical excisional procedure; Other Names: Abscission; Extirpation; Surgical Removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity ratio for SC versus CC samples	Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.	One-time, up to 90 days
Specificity ratio for SC versus CC samples	Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.	One-time, up to 90 days
Positive percent agreement	Will be defined as the probability of positive on SC given positive on CC, expressed as a percent. Will report point estimate and 95% CIs.	One-time, up to 90 days
Negative percent agreement	Will be defined as the probability of negative on SC given negative on CC, expressed as a percent. Will report point estimate and 95% CIs.	One-time, up to 90 days
Clinical sensitivity for self-collected (SC) samples	Will be defined as the probability of a positive SC sample given cervical intraepithelial neoplasia (CIN)2+. Will report point estimate and 95% confidence intervals (CIs).	One-time, up to 90 days
Clinical sensitivity for clinician-collected (CC) samples	Will be defined as the probability of a positive CC sample given CIN2+. Will report point estimate and 95% CIs.	One-time, up to 90 days
Clinical specificity for SC samples	Will be defined as the probability of a negative SC sample given < CIN2. Will report point estimate and 95% CIs.	One-time, up to 90 days
Clinical specificity for CC samples	Will be defined as the probability of a negative CC sample given < CIN2. Will report point estimate and 95% CIs.	One-time, up to 90 days
False positive rate (FPR) for SC samples	Will be defined as the probability of a positive SC sample given < CIN2. Will report point estimate and 95% CIs.	One-time, up to 90 days
FPR for CC samples	Will be defined as the probability of a positive CC sample given < CIN2. Will report point estimate and 95% CIs.	One-time, up to 90 days
False negative rate (FNR) for SC samples	Will be defined as the probability of a negative SC sample given CIN2+. Will report point estimate and 95% CIs.	One-time, up to 90 days
FNR for CC samples	Will be defined as the probability of a negative CC sample given CIN2+. Will report point estimate and 95% CIs.	One-time, up to 90 days
False positive (FP) ratio for SC versus CC samples	Will be defined as the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs.	One-time, up to 90 days
False negative (FN) ratio for SC versus CC samples	Will be defined as the FNR of SC divided by the FBR of CC. Will report point estimate and 95% CIs.	One-time, up to 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human factors affecting usability	Will be assessed by questionnaire data.	One-time, up to 90 days
Human factors affecting acceptability	Will be assessed by questionnaire data.	One-time, up to 90 days
Human factors affecting references for self-collection	Will be assessed by questionnaire data.	One-time, up to 90 days

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Vikrant V Sahasrabuddhe, National Cancer Institute Division of Cancer Prevention

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Uterine Cervical Neoplasms; Papillomavirus Infections; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Urogenital Surgical Procedures; Genetic Techniques; Gynecologic Surgical Procedures; Obstetric Surgical Procedures; Diagnostic Techniques, Obstetrical and Gynecological; Molecular Diagnostic Techniques; Specimen Handling; Colposcopy; Human Papillomavirus DNA Tests
• Other Study ID Numbers: NCI-2024-07724 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); LMI-001-A-S03 (Other Identifier: DCP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No