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.
Abnormal uterine bleeding
Postmenopausal bleeding
Abnormal uterine bleeding
One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)
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
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Treatment groupsSee each treatment group below.
Mayo Clinic
Lead sponsor