This study aims to develop screening tests for endometrial cancer, ovarian cancer, and cervical cancer. The intent of the current phase of this research is to determine if it is clinically feasible and acceptable for women to use a standard vaginal tampon to collect a sample of endometrial cells, cervical cells and vaginal fluid prior to their scheduled clinical pelvic exam. Specialized testing on the samples obtained from the tampons will help researchers to better understand endometrial, ovarian, and cervical cancers and continue with development of a screening test. The samples collected during this study will be used for research related to endometrial cancer, ovarian cancer, cervical cancer, and non-cancer conditions such as abnormal uterine bleeding, non-cancerous endometrial condition (Fibroids, Polyps, Adenomyosis, Endometriosis) and benign ovarian mass.
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: A Phase II Clinical Study
Protocol No
MAYO-ECHO-STUDY
Staff Member
Emily Davidson
Phase
II
Summary
Objective
The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma. A sample of the vaginal fluid pool will be collected via a standard tampon from each study participant prior to any clinical exams or procedures. A peripheral blood sample will be collected from each study participant prior to any clinical exams or procedures.
Study Sites
Froedtert Hospital
Status
OPEN TO ACCRUAL
Categories
ClinicalTrials.gov