National Cancer Institute (NCI)
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.
Cervical Carcinoma
Human Papillomavirus Infection
Biospecimen Collection
Cervical Biopsy
Colposcopy
Electronic Health Record Review
Endocervical Curettage
Excision
HPV Self-Collection
Human Papillomavirus Test
Questionnaire Administration
NA
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 |
| Estimated Enrollment : | 500 participants |
| Masking : | NONE |
| Masking Description : | SC and CC samples will be handled similarly for post-collection processing and will be shipped to designated testing laboratories for HPV testing as per Roche-specified frequency and stability nformation. The sample tubes/containers will be pre-labeled to ensure that the testing laboratories cannot make linkages between an individual's sample pairs (SC, CC) thereby permitting unbiased and blinded testing and reporting. |
| Primary Purpose : | PREVENTION |
| Official Title : | NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial |
| Actual Study Start Date : | 2024-09-11 |
| Estimated Primary Completion Date : | 2025-07-14 |
| Estimated Study Completion Date : | 2025-10-14 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 25 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
NOT YET RECRUITING
University of Alabama at Birmingham Cancer Center
Birmingham, Albama, United States, 35233
NOT YET RECRUITING
UCSF Medical Center-Parnassus
San Francisco, California, United States, 94143
NOT YET RECRUITING
Yale University
New Haven, Connecticut, United States, 06520
NOT YET RECRUITING
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
NOT YET RECRUITING
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
NOT YET RECRUITING
UofL Health Medical Center Northeast
Louisville, Kentucky, United States, 40245
NOT YET RECRUITING
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
NOT YET RECRUITING
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
RECRUITING
University of Michigan Comprehensive Cancer Center
Ann Arbor, Road cancer, United States, 48109
RECRUITING
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
NOT YET RECRUITING
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
RECRUITING
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
NOT YET RECRUITING
Montefiore Medical Center-Einstein Campus
Bronx, New York, United States, 10461
NOT YET RECRUITING
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
RECRUITING
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
NOT YET RECRUITING
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
NOT YET RECRUITING
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
NOT YET RECRUITING
University of Oklahoma Health Sciences Center
Ololama City, Okholohan, United States, 73104
RECRUITING
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
NOT YET RECRUITING
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
NOT YET RECRUITING
M D Anderson Cancer Center
Houston, Texas, United States, 77030
RECRUITING
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
NOT YET RECRUITING
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
NOT YET RECRUITING
University of Washington Medical Center - Northwest
Seattle, Washington, United States, 98133
NOT YET RECRUITING
University of Puerto Rico
San Juan, Puerto Rico, 00936