Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)
NCT ID: NCT06498661
Last Updated: 2025-10-29
Study Results
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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ACTIVE_NOT_RECRUITING
NA
520 participants
INTERVENTIONAL
2024-06-26
2026-12-31
Brief Summary
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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.
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Detailed Description
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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 Becton, Dickinson and Company (BD) Onclarity (trademark) HPV assay: Any high risk (HR) HPV genotype, HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/58, HPV35/39/68, HPV56/59/66.
EXPLORATORY OBJECTIVE:
I. To evaluate human factors affecting usability, acceptability, and preferences for self-collection.
OBJECTIVE FOR PILOT PHASE:
I. The emphasis in the pilot phase of the study will be on streamlining and refining study procedures and clinical and operational workflows.
OUTLINE:
Patients 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.
After completion of study intervention (one time), laboratory results available within 90 days are collected for study analysis purposes.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Prevention (self-collected and clinician-collected samples)
Patients 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.
Biospecimen Collection
Undergo collection of cervical samples by clinician
Cervical Biopsy
Undergo cervical biopsy conducted by clinician
Colposcopy
Undergo colposcopy conducted by clinician
Electronic Health Record Review
Ancillary studies
Endocervical Curettage
Undergo endocervical curettage conducted by clinician
Excision
Undergo cervical excisional procedure conducted by clinician
HPV Self-Collection
Undertake self-collection of vaginal samples
Human Papillomavirus Test
Undergo HPV testing of self-collected vaginal samples and cervical samples
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of cervical samples by clinician
Cervical Biopsy
Undergo cervical biopsy conducted by clinician
Colposcopy
Undergo colposcopy conducted by clinician
Electronic Health Record Review
Ancillary studies
Endocervical Curettage
Undergo endocervical curettage conducted by clinician
Excision
Undergo cervical excisional procedure conducted by clinician
HPV Self-Collection
Undertake self-collection of vaginal samples
Human Papillomavirus Test
Undergo HPV testing of self-collected vaginal samples and cervical samples
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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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
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
M D Anderson Cancer Center
Houston, Texas, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
University of Puerto Rico
San Juan, , Puerto Rico
Countries
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Other Identifiers
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NCI-2024-05879
Identifier Type: REGISTRY
Identifier Source: secondary_id
LMI-001-A-S01
Identifier Type: OTHER
Identifier Source: secondary_id
LMI-001-A-S01
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2024-05879
Identifier Type: -
Identifier Source: org_study_id
NCT06676150
Identifier Type: -
Identifier Source: nct_alias
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