Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Trial Parameters
Brief Summary
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. This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.
Eligibility Criteria
Inclusion Criteria for Cohort 1: Patients will be ≥45 years of age and meet one of the following criteria: * Abnormal uterine bleeding * Postmenopausal bleeding OR Patients ages 18 - 44 years of age and meet these criteria * Abnormal uterine bleeding * One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use) Exclusion Criteria for Cohort 1: * Prior hysterectomy * Current known pregnancy diagnosis * Any prior pelvic or vaginal radiotherapy * Any prior cancer (except basal cell skin cancer) within the past 5 years * Chemotherapy within the past 5 years * Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia * Current biopsy-proven endometrial cancer or endometrial hyperplasia * Current biopsy-proven benign endometrial polyp * Endometrial biopsy/sampling within the preceding 1 month showing benign endometrium Inclusion Criteria for Cohort 2: Patients will be ≥18 years of age and meet at least one of the following criteria: * Presence o