NCI Cervical Cancer 'Last Mile' Initiative 'Self-Collection for HPV Testing to Improve Cervical Cancer Prevention' (SHIP) Trial

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
NOT_YET_RECRUITING
Birmingham
California
UCSF Medical Center-Parnassus
NOT_YET_RECRUITING
San Francisco
Connecticut
Yale University
RECRUITING
New Haven
Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING
Miami
Georgia
Emory University Hospital/Winship Cancer Institute
NOT_YET_RECRUITING
Atlanta
Kentucky
UofL Health Medical Center Northeast
NOT_YET_RECRUITING
Louisville
Louisiana
Louisiana State University Health Science Center
NOT_YET_RECRUITING
New Orleans
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
Michigan
University of Michigan Comprehensive Cancer Center
NOT_YET_RECRUITING
Ann Arbor
Minnesota
Minneapolis VA Medical Center
NOT_YET_RECRUITING
Minneapolis
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
New Mexico
University of New Mexico Cancer Center
NOT_YET_RECRUITING
Albuquerque
New York
NYP/Weill Cornell Medical Center
NOT_YET_RECRUITING
New York
Montefiore Medical Center-Einstein Campus
NOT_YET_RECRUITING
The Bronx
Ohio
University of Cincinnati Cancer Center-UC Medical Center
NOT_YET_RECRUITING
Cincinnati
Cleveland Clinic Foundation
NOT_YET_RECRUITING
Cleveland
Oklahoma
University of Oklahoma Health Sciences Center
NOT_YET_RECRUITING
Oklahoma City
Pennsylvania
University of Pennsylvania/Abramson Cancer Center
RECRUITING
Philadelphia
UPMC-Magee Womens Hospital
NOT_YET_RECRUITING
Pittsburgh
Texas
M D Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Utah
Huntsman Cancer Institute/University of Utah
NOT_YET_RECRUITING
Salt Lake City
Virginia
Virginia Commonwealth University/Massey Cancer Center
RECRUITING
Richmond
Washington
University of Washington Medical Center - Northwest
NOT_YET_RECRUITING
Seattle
Other Locations
Puerto Rico
University of Puerto Rico
RECRUITING
San Juan
Time Frame
Start Date: 2024-09-13
Estimated Completion Date: 2025-10-14
Participants
Target number of participants: 500
Treatments
Experimental: Prevention (self-collected and clinician-collected samples)
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.
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov