Actively Recruiting
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Led by Mayo Clinic · Updated on 2026-04-17
3110
Participants Needed
24
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 45 years or older with abnormal uterine bleeding or postmenopausal bleeding
- Patients aged 18 to 44 years with abnormal uterine bleeding plus one risk factor for endometrial cancer (BMI 30 or higher, PCOS, or Tamoxifen use)
- Patients aged 18 years or older with biopsy-proven endometrial cancer or atypical endometrial hyperplasia with planned surgical intervention
- Patients aged 18 years or older with a cervix and abnormal cervical/endocervical Pap test, cervical mass, or planned cervical surgical biopsy/removal
- Patients aged 45 years or older undergoing hysterectomy or gynecologic surgery for benign uterine or gynecologic conditions such as fibroids, endometriosis, adenomyosis, or benign endometrial polyps
- Patients aged 45 years or older presenting for gynecologic wellness exam with no recent changes in medical conditions or medications
- Patients aged 50 years or older who are postmenopausal with at least one intact ovary, diagnosed with or suspected of adnexal mass or early-stage ovarian cancer with planned surgery
- Women aged 18 years or older with clinically probable ovarian, fallopian tube, or primary peritoneal cancer newly diagnosed without prior neoadjuvant therapy and at least one intact ovary
You will not qualify if you...
- Prior hysterectomy
- Current known pregnancy
- Prior pelvic or vaginal radiotherapy
- Any cancer diagnosis (except basal cell skin cancer) within the past 5 years
- Chemotherapy within the past 5 years
- Current biopsy-proven cervical, vaginal, vulvar, or endometrial cancer or dysplasia
- Current biopsy-proven benign endometrial polyp or biopsy showing benign endometrium within the past month
- Prior intervention or surgery intended to completely remove the target pathology
- Undergoing surgery for recurrent or metastatic endometrial or ovarian cancer
- History of pelvic or vaginal radiation therapy
- Surgical candidates for recurrent ovarian cancer
- Clinically suspected advanced stage ovarian cancer (Stage III or IV)
- Pap test or cervical biopsy within the past month
- Endometrial biopsy or hysteroscopy within 1 to 2 weeks or 1 month depending on cohort
- Surgery within the past 3 months
- Patients presenting for colposcopy for surveillance without current abnormalities
- Known synchronous endometrial cancer or hyperplasia with ovarian cancer
- Known cervical, vaginal, or vulvar dysplasia or cancer
- Criteria met for inclusion in other study cohorts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
My GYN Care
Miami, Florida, United States, 33156
Active, Not Recruiting
4
Genoma Research, Inc.
Miami, Florida, United States, 33173
Actively Recruiting
5
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
6
Signature Women's Healthcare, LLC
Pembroke Pines, Florida, United States, 33029
Active, Not Recruiting
7
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239
Actively Recruiting
8
Piedmont Healthcare
Atlanta, Georgia, United States, 30318
Actively Recruiting
9
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
10
Providea Health Partners, LLC
Evergreen Park, Illinois, United States, 60805
Active, Not Recruiting
11
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
12
Valley OB-GYN Clinic
Saginaw, Michigan, United States, 48602
Actively Recruiting
13
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
14
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39213
Actively Recruiting
15
The Woman's Health Pavilion
Howard Beach, New York, United States, 11414
Actively Recruiting
16
The Woman's Health Pavilion
Westbury, New York, United States, 11590
Actively Recruiting
17
Altru Health System
Grand Forks, North Dakota, United States, 58206
Actively Recruiting
18
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
19
Total Women's Care of the Heights
Houston, Texas, United States, 77018
Actively Recruiting
20
Medical Colleagues of Texas, LLP
Katy, Texas, United States, 77450
Actively Recruiting
21
Virginia Commonwealth University/ Massey Cancer Center
Richmond, Virginia, United States, 23219
Actively Recruiting
22
Mayo Clinic Health System - Northwest Wisconsin
Eau Claire, Wisconsin, United States, 54703
Actively Recruiting
23
Mayo Clinic Health System - Southwest Wisconsin
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
24
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Active, Not Recruiting
Research Team
M
Maureen A Lemens, BSN
CONTACT
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here