Actively Recruiting
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical Study
Led by Mayo Clinic · Updated on 2026-04-17
3110
Participants Needed
24
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are developing a test to detect gynecologic cancers, including endometrial, ovarian, and cervical cancers, by identifying specific methylated DNA markers and high-risk human papilloma virus in vaginal fluid and blood plasma. The goal is to improve early detection, especially for women presenting with abnormal uterine bleeding or postmenopausal bleeding, symptoms often linked to these cancers or their precursors. Early detection is crucial to increase the chances of cure and reduce the need for invasive procedures. The study includes multiple groups of women with different gynecologic conditions such as abnormal uterine bleeding, biopsy-confirmed endometrial or ovarian cancer, cervical abnormalities, benign uterine conditions, and healthy controls. Participants will provide vaginal fluid samples collected by a healthcare provider and blood samples before any exams or procedures. This observational study involves testing these samples for cancer-specific markers to develop and validate predictive models for detecting these cancers. Participants will undergo sample collection and clinical evaluations as part of their usual care, including biopsies or surgery when indicated. Researchers will assess the ability of the methylated DNA marker panels to identify cancer and precancerous conditions with high specificity. The study also monitors false positive rates among women with benign conditions. The total participation time varies depending on the patient group, with key outcomes measured over an 18-month period.
CONDITIONS
Brief 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...
- Female patients 18 years of age or older
- Patients 45 years or older with abnormal uterine bleeding or postmenopausal bleeding
- Patients aged 18 to 44 with abnormal uterine bleeding and at least one risk factor for endometrial cancer (BMI 30 or higher, PCOS, or Tamoxifen use)
- Patients 18 years or older with biopsy-proven endometrial cancer, atypical endometrial hyperplasia, or endometrial intraepithelial neoplasia planning surgical intervention
- Patients 18 years or older with abnormal cervical Pap test or cervical mass requiring biopsy or surgery
- Patients 45 years or older undergoing surgery for benign gynecologic conditions such as fibroids, endometriosis, adenomyosis, or benign endometrial polyps
- Healthy female patients 45 years or older presenting for gynecologic wellness exam without gynecologic cancers or precancers
- Patients 50 years or older, postmenopausal, with adnexal mass planned for surgery
- Patients 18 years or older with clinically probable ovarian, fallopian tube, or primary peritoneal cancer without prior neoadjuvant therapy
You will not qualify if you...
- Prior hysterectomy
- Current known pregnancy
- 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 hyperplasia in the abnormal uterine bleeding cohort
- Current biopsy-proven benign endometrial polyp in the abnormal uterine bleeding cohort
- Endometrial biopsy or office hysteroscopy within 1 month prior to surgery or enrollment in certain cohorts
- Undergoing surgery for recurrent or metastatic endometrial cancer
- Presence of concomitant biopsy-proven cervical dysplasia
- Prior intervention or surgery intended to completely remove the target pathology during the current episode
- Prior total hysterectomy (cervix removed) for any indication
- Patients with recurrent ovarian cancer or clinically suspected advanced stage ovarian cancer
- Patients presenting for colposcopy after prior treatment without current abnormalities
- Criteria met for inclusion in other study cohorts for healthy controls
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants provide vaginal fluid and blood samples collected by a healthcare provider prior to any exams or procedures to detect endometrial, ovarian, and cervical cancers or their precursors.
1 visit for sample collection
Duration - Up to 18 months
Participants are observed over time to validate the performance of methylated DNA markers in identifying gynecologic cancers and assess false positive rates among women undergoing surgical removal of benign gynecologic conditions.
Follow-up assessments as needed depending on cohort assignment
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
C
Clinical Trials Referral Office
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
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