Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Masz 25 lat lub więcej.
- •Jesteś skierowana na kolposkopię lub zabieg usuwający zmiany z szyjki macicy z powodu nieprawidłowych wyników cytologii lub testu HPV w ciągu ostatniego roku.
- •Wyrażasz zgodę na udział w badaniu i możesz wypełnić ankiety.
- •Masz nienaruszoną szyjkę macicy.
- •Jesteś gotowa wykonać koloskopię oraz ewentualne dodatkowe badania (biopsja, pobranie wycinka z kanału szyjki macicy lub zabieg chirurgiczny), jeśli lekarz uzna to za konieczne.
✗ Disqualifies
- •Jesteś w ciąży lub urodziłaś w ciągu ostatnich 3 miesięcy.
- •Miałaś zabieg usunięcia lub zniszczenia części szyjki macicy (np. LEEP, stożek) w ciągu ostatniego roku.
- •Miałaś usuniętą macicę (częściowo lub całkowicie, z szyjką macicy lub bez) w przeszłości.
- •Masz inne choroby, które według lekarza mogą utrudniać udział w badaniu.
- •Ostatnio brałaś udział w innym badaniu dotyczącym raka szyjki macicy.
- •Masz nietypowe krwawienie lub bóle w miednicy.
Simplified criteria — AI translation
Trial details
- Minimum age
- 25 Years
- Last updated (source)
- July 7, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (18)
University of Alabama at Birmingham Cancer Center
Birmingham, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Louisiana State University
Lafayette, United States
Louisiana State University Health Science Center
New Orleans, United States
Minneapolis VA Medical Center
Minneapolis, United States
University of New Mexico Cancer Center
Albuquerque, United States
Montefiore Medical Center-Einstein Campus
The Bronx, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, United States
University of Oklahoma Health Sciences Center
Oklahoma City, United States
University of Oklahoma
Oklahoma City, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, United States
UPMC-Magee Womens Hospital
Pittsburgh, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, United States
UT MD Anderson Cancer Center
Houston, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, United States
West Virginia University Healthcare
Morgantown, United States
Trial contact
Warner K. Huh
Warner K. Huh
PRINCIPAL_INVESTIGATOR
Lisa C. Flowers
Lisa C. Flowers
PRINCIPAL_INVESTIGATOR
Michael E. Hagensee
Michael E. Hagensee
PRINCIPAL_INVESTIGATOR
Elisheva Danan
Elisheva Danan
PRINCIPAL_INVESTIGATOR
Cosette M. Wheeler
Cosette M. Wheeler
PRINCIPAL_INVESTIGATOR
Mark H. Einstein
Mark H. Einstein
PRINCIPAL_INVESTIGATOR
Lisa Rahangdale
Lisa Rahangdale
PRINCIPAL_INVESTIGATOR
Leeya F. Pinder
Leeya F. Pinder
PRINCIPAL_INVESTIGATOR
Jacqueline A. Bohn
Jacqueline A. Bohn
PRINCIPAL_INVESTIGATOR
Jacqueline A. Bohn
Carmen Guerra
Carmen Guerra
PRINCIPAL_INVESTIGATOR
Harold C. Wiesenfeld
Harold C. Wiesenfeld
PRINCIPAL_INVESTIGATOR
Elizabeth Y. Chiao
Elizabeth Y. Chiao
PRINCIPAL_INVESTIGATOR
Deanna L. Kepka
Deanna L. Kepka
PRINCIPAL_INVESTIGATOR
Krista S. Pfaendler
Krista S. Pfaendler
PRINCIPAL_INVESTIGATOR
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/8/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.