RecruitingNCT05051722

Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer

Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical Study


Sponsor

Mayo Clinic

Enrollment

3,110 participants

Start Date

Aug 3, 2021

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether certain chemical markers in a urine or tissue sample (called methylated DNA markers) can reliably detect endometrial, ovarian, or cervical cancer at an early stage — potentially offering a less invasive way to screen for these gynecological cancers. **You may be eligible if...** - You are a woman experiencing abnormal uterine bleeding or postmenopausal bleeding - If you are 18–44 years old, you also need a risk factor such as obesity (BMI ≥30), PCOS, or taking Tamoxifen - You are being evaluated for a possible gynecological cancer or have certain lesions being investigated **You may NOT be eligible if...** - You have previously had a hysterectomy - You are currently pregnant - You have had pelvic radiation in the past - You have had another cancer (other than basal cell skin cancer) in the past 5 years - You have already been diagnosed with the cancer this study is trying to detect Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Clinic

Phoenix, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

My GYN Care

Miami, Florida, United States

Genoma Research, Inc.

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

Signature Women's Healthcare, LLC

Pembroke Pines, Florida, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Providea Health Partners, LLC

Evergreen Park, Illinois, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Valley OB-GYN Clinic

Saginaw, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

The Woman's Health Pavilion

Howard Beach, New York, United States

The Woman's Health Pavilion

Westbury, New York, United States

Altru Health System

Grand Forks, North Dakota, United States

Cleveland Clinic

Cleveland, Ohio, United States

Total Women's Care of the Heights

Houston, Texas, United States

Medical Colleagues of Texas, LLP

Katy, Texas, United States

Virginia Commonwealth University/ Massey Cancer Center

Richmond, Virginia, United States

Mayo Clinic Health System - Northwest Wisconsin

Eau Claire, Wisconsin, United States

Mayo Clinic Health System - Southwest Wisconsin

La Crosse, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05051722


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