Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)
- Conditions
- Cervical CarcinomaHuman Papillomavirus Infection
- Interventions
- Procedure: Biospecimen CollectionProcedure: Cervical BiopsyProcedure: ColposcopyOther: Electronic Health Record ReviewProcedure: Endocervical CurettageProcedure: ExcisionProcedure: HPV Self-CollectionProcedure: Human Papillomavirus TestOther: Questionnaire AdministrationOther: Survey Administration
- Registration Number
- NCT06611553
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
- Detailed Description
PRIMARY OBJECTIVE:
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: Any high risk (HR) HPV genotype, HPV16, 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 colposcopy with or without 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 500
- 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 cell 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 standard of care (SOC) purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prevention (self-collected and clinician-collected samples) Biospecimen Collection Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Prevention (self-collected and clinician-collected samples) Cervical Biopsy Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Prevention (self-collected and clinician-collected samples) Colposcopy Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Prevention (self-collected and clinician-collected samples) Electronic Health Record Review Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Prevention (self-collected and clinician-collected samples) Endocervical Curettage Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Prevention (self-collected and clinician-collected samples) Excision Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Prevention (self-collected and clinician-collected samples) HPV Self-Collection Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Prevention (self-collected and clinician-collected samples) Human Papillomavirus Test Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Prevention (self-collected and clinician-collected samples) Questionnaire Administration Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated. Prevention (self-collected and clinician-collected samples) Survey Administration Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.
- Primary Outcome Measures
Name Time Method Clinical sensitivity for self-collected (SC) samples One-time, up to 90 days Will be defined as the probability of testing human papillomavirus (HPV) positive on SC sample given cervical intraepithelial neoplasia (CIN)2+. Will report point estimate and 95% confidence intervals (CIs).
Clinical sensitivity for clinician-collected (CC) samples One-time, up to 90 days Will be defined as the probability of testing HPV positive on CC sample given CIN2+. Will report point estimate and 95% CIs.
Clinical specificity for SC samples One-time, up to 90 days Will be defined as the probability of testing HPV negative on SC sample given \< CIN2. Will report point estimate and 95% CIs.
Clinical specificity for CC samples One-time, up to 90 days Will be defined as the probability of testing HPV negative on CC sample given \< CIN2. Will report point estimate and 95% CIs.
False positive rate (FPR) for SC samples One-time, up to 90 days Will be defined as the probability of testing HPV positive on SC sample given \< CIN2. Will report point estimate and 95% CIs.
FPR for CC samples One-time, up to 90 days Will be defined as the probability of testing HPV positive on CC sample given \< CIN2. Will report point estimate and 95% CIs.
False negative rate (FNR) for SC samples One-time, up to 90 days Will be defined as the probability of testing HPV negative on SC given CIN2+. Will report point estimate and 95% CIs.
FNR for CC samples One-time, up to 90 days Will be defined as the probability of testing HPV negative on CC given CIN2+. Will report point estimate and 95% CIs.
Sensitivity ratio for SC versus CC samples One-time, up to 90 days Will be defined as the sensitivity of SC divided by the sensitivity of CC. Will report point estimate and 95% CIs.
Specificity ratio for SC versus CC samples One-time, up to 90 days Will be defined as the specificity of SC divided by the specificity of CC. Will report point estimate and 95% CIs.
False positive (FP) ratio for SC versus CC samples One-time, up to 90 days The FP ratio is the FPR of SC divided by the FPR of CC. Will report point estimate and 95% CIs.
False negative (FN) ratio for SC versus CC samples One-time, up to 90 days The FN ratio is the FNR of SC divided by the FNR of CC. Will report point estimate and 95% CIs.
Positive percent agreement One-time, up to 90 days 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.
Negative percent agreement One-time, up to 90 days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
UCSF Medical Center-Parnassus
🇺🇸San Francisco, California, United States
Yale University
🇺🇸New Haven, Connecticut, 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
UofL Health Medical Center Northeast
🇺🇸Louisville, Kentucky, United States
Louisiana State University Health Science Center
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Minneapolis VA Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Center-Einstein Campus
🇺🇸Bronx, New York, United States
NYP/Weill Cornell Medical Center
🇺🇸New York, 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
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania/Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
UPMC-Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute/University of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
University of Washington Medical Center - Northwest
🇺🇸Seattle, Washington, United States
University of Puerto Rico
🇵🇷San Juan, Puerto Rico