Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)
SHIP-A-S01
NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial LMI-001-A-S01
2 other identifiers
interventional
750
2 countries
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2024
CompletedFirst Submitted
Initial submission to the registry
July 10, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
April 21, 2026
March 1, 2026
2.5 years
July 10, 2024
April 18, 2026
Conditions
Outcome Measures
Primary Outcomes (23)
Clinical sensitivity for self-collected (SC) samples (Group A)
Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given disease positive (e.g., cervical intraepithelial neoplasia \[CIN\]2+). Will report point estimate and 95% confidence intervals (CIs).
One-time, up to 30 days
Clinical sensitivity for clinician-collected (CC) samples (Group A)
Will be defined as the probability of testing HPV positive on CC sample given disease positive (e.g., CIN2+). Will report point estimate and 95% CIs.
One-time, up to 30 days
Sensitivity ratio for SC versus CC samples (Group A)
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 30 days
Difference in clinical sensitivity between SC and CC samples (Group A)
Will report point estimate and 95% CIs.
One-time, up to 30 days
Clinical specificity for SC samples (Group A)
Will be defined as the probability of testing HPV negative on SC sample given disease negative (e.g., \< CIN2). Will report point estimate and 95% CIs.
One-time, up to 30 days
Clinical specificity for CC samples (Group A)
Will be defined as the probability of testing HPV negative on CC sample given disease negative (e.g., \< CIN2). Will report point estimate and 95% CIs.
One-time, up to 30 days
Specificity ratio for SC versus CC samples (Group A)
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 30 days
Difference in clinical specificity between SC and CC samples (Group A)
Will report point estimate and 95% CIs.
One-time, up to 30 days
False positive rate (FPR) for SC samples (Group A)
Will be defined as the probability of testing HPV positive on SC sample given \< CIN2. Will report point estimate and 95% CIs.
One-time, up to 30 days
FPR for CC samples (Group A)
Will be defined as the probability of testing HPV positive on CC sample given \< CIN2. Will report point estimate and 95% CIs.
One-time, up to 30 days
FPR ratio for SC versus CC samples (Group A)
The FPR ratio is the FPR of SC divided by the FP of CC. Will report point estimate and 95% CIs.
One-time, up to 30 days
Difference in FPR ratio between SC and CC samples (Group A)
Will report point estimate and 95% CIs.
One-time, up to 30 days
False negative rate (FNR) for SC samples (Group A)
Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs.
One-time, up to 30 days
FNR for CC samples (Group A)
Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs.
One-time, up to 30 days
FNR ratio for SC versus CC samples (Group A)
The FNR ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs.
One-time, up to 30 days
Difference in FNR ratio between SC and CC samples (Group A)
Will report point estimate and 95% CIs.
One-time, up to 30 days
Positive percent agreement (Group A)
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 30 days
Negative percent agreement (Group A)
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 30 days
Positive percent agreement (Group A and Group B)
Will report point estimate and 95% CIs.
One-time, up to 30 days
Negative percent agreement (Group A and Group B)
Will report point estimate and 95% CIs.
One-time, up to 30 days
Cohen's Kappa (Group A and Group B)
Will be described as a measure of agreement beyond chance between SC and CC samples, and values will be interpreted as follows: 0.00-0.19 as poor, 0.20-0.39 as fair, 0.40-0.59 as moderate, 0.60-0.79 as good, and 0.80-1.00 as excellent agreement beyond chance. Will report point estimate and 95% CIs.
One-time, up to 30 days
Test positivity rates (Group A and Group B)
Will report point estimate and 95% CIs.
One-time, up to 30 days
Rate of invalid test results (Group A and Group B)
Will report point estimate and 95% CIs.
One-time, up to 30 days
Other Outcomes (3)
Human factors affecting usability
One-time, up to 30 days
Human factors affecting acceptability
One-time, up to 30 days
Human factors affecting references for self-collection
One-time, up to 30 days
Study Arms (2)
Group A (self-collected and clinician-collected samples)
EXPERIMENTALPatients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
Group B (self-collected and clinician-collected samples)
EXPERIMENTALPatients undergo self-collection of two vaginal samples and then undergo clinician-collection of 1 or 2 cervical test samples. Patients may undergo standard of care colposcopy with biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
Interventions
Undergo cervical biopsy conducted by clinician
Undergo colposcopy conducted by clinician
Undergo collection of cervical samples by clinician
Ancillary studies
Undergo endocervical curettage conducted by clinician
Undergo cervical excisional procedure conducted by clinician
Undertake self-collection of vaginal samples
Undergo HPV testing of self-collected vaginal samples and cervical samples
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- GROUP A: Willingness and ability to provide a documented informed consent
- GROUP A: Is 25 years or older
- GROUP A: Has an intact cervix
- GROUP A: Has had a referral for colposcopy or cervical excisional procedure 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
- GROUP A: 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
- GROUP B: Willingness and ability to provide a documented informed consent
- GROUP B: Is 25 years or older
- GROUP B: Has an intact cervix
- GROUP B: Eligible for regular cervical cancer screening by current national guidelines
You may not qualify if:
- GROUP A: Is pregnant when presenting for the referral visit or gave birth within the past 3 months
- GROUP A: 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
- GROUP A: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- GROUP A: Known medical conditions that, in the opinion of the investigator, preclude study participation
- GROUP A: Previous participation in the SHIP trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
- GROUP A: Is experiencing unusual bleeding or pelvic pain
- GROUP B: Is known to be pregnant when presenting for the screening visit or gave birth within the past 3 months
- GROUP B: Has a known history of excisional or ablative therapy to the cervix (e.g., LEEP, cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the screening visit
- GROUP B: Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
- GROUP B: Known medical conditions that, in the opinion of the investigator, preclude study participation
- GROUP B: Previous participation in the SHIP Trial (participation is defined as completing the self-collection sampling) or another cervical cancer screening study that involved vaginal sampling within the past 12 months
- GROUP B: Is experiencing any bleeding (including menstruation) or pelvic pain
- GROUP B: Is experiencing any active vaginal infection or has used any vaginal products in 48 hours previous to study sample collection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
University of Puerto Rico
San Juan, 00936, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vikrant V Sahasrabuddhe
National Cancer Institute Division of Cancer Prevention
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Samples will be shipped to BD-specified testing laboratories for blinded HPV testing as per BD-specified frequency and stability information.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2024
First Posted
July 12, 2024
Study Start
June 26, 2024
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
April 21, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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."