Trial details
HSIL/ACIS/Early Cervical Cancer: What Are The Current Causative HPV Subtypes in the Era of HPV Vaccination?
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Trial short name: HPV Subtypes
Official title: HSIL/ACIS/Early Cervical Cancer: What Are The Current Causative HPV Subtypes in the Era of HPV Vaccination?
Principal Investigator: Dr. Al Covens
Cancer type: Gynecology
Cancer location: Cervix
Disease stage: Early Cancer
Trial phase: Other
Intervention: Other: Observation
Registration #: NCT02937155
Trial description:
The purpose of this study is to compare human papilloma virus (HPV) subtypes in women who have received the HPV vaccine to women who have not received the vaccine. Women who have high grade intraepithelial dysplasia (HSIL), adenocarcinoma in situ (ACIS) or early cervical cancer and who are to have a cervical biopsy may be able to participate. This is an observational study which will analyze tissue samples obtained during the patient’s biopsy.
Inclusion Criteria: • Women ≥ 18 years old • Presenting with cervical high grade intraepithelial dysplasia (HSIL), adenocarcinoma in situ (ACIS), or early cervical cancer • Expected to have a cervical biopsy, LEEP, or cone biopsy Exclusion Criteria: • A history of HSIL, ACIS, or early cervical cancer prior to 2010 • Patients who are unable to provide consent • Women who have had a previous LEEP or cone biopsy