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.
Cervical Carcinoma, Human Papillomavirus Infection
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.
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)
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University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States, 35233
UCSF Medical Center-Parnassus, San Francisco, California, United States, 94143
Yale University, New Haven, Connecticut, United States, 06520
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States, 33136
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States, 30322
UofL Health Medical Center Northeast, Louisville, Kentucky, United States, 40245
Louisiana State University Health Science Center, New Orleans, Louisiana, United States, 70112
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States, 21287
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States, 48109
Minneapolis VA Medical Center, Minneapolis, Minnesota, United States, 55417
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
25 Years to
FEMALE
No
National Cancer Institute (NCI),
Vikrant V Sahasrabuddhe, PRINCIPAL_INVESTIGATOR, National Cancer Institute Division of Cancer Prevention
2025-05-14