Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical Study
Mayo Clinic
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.
Description
Detection of endometrial, ovarian, and cervical cancers at an early stage vastly increases the chances of cure and may also avert morbidity secondary to surgical staging, radiation, and/or chemotherapy. Despite the great successes of cervical cancer screening, comparable early detection methods for other gynecologic cancers and their precursors are not available. While nearly 1.5 million women per year in the United States are evaluated for abnormal uterine bleeding (AUB) or postmenopausal bleeding (PMB), the most common symptom of endometrial cancer, most undergo an invasive diagnostic biopsy…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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-pr…
Interventions
- Diagnostic TestVaginal Fluid Collection
A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.
- Diagnostic TestBlood Collection
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Locations (24)
- Mayo ClinicPhoenix, Arizona
- Mayo ClinicJacksonville, Florida
- My GYN CareMiami, Florida
- Genoma Research, Inc.Miami, Florida
- Orlando HealthOrlando, Florida
- Signature Women's Healthcare, LLCPembroke Pines, Florida