RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-03
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05051722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Maureen A Lemens, BSN
CONTACT
507-293-1487
lemens.maureen@mayo.edu
Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Jamie N Bakkum-Gamez, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Phoenix, Arizona, 85054
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
My GYN Care
Miami, Florida, 33156
United States
Genoma Research, Inc.
Miami, Florida, 33173
United States
Signature Women's Healthcare, LLC
Pembroke Pines, Florida, 33029
United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
United States
University of Chicago
Chicago, Illinois, 60637
United States
Providea Health Partners, LLC
Evergreen Park, Illinois, 60805
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Valley OB-GYN Clinic
Saginaw, Michigan, 48602
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39213
United States
The Woman's Health Pavilion
Howard Beach, New York, 11414
United States
The Woman's Health Pavilion
Westbury, New York, 11590
United States
Altru Health System
Grand Forks, North Dakota, 58206
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Medical Colleagues of Texas, LLP
Katy, Texas, 77450
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Jamie N Bakkum-Gamez, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-03
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2021-08-03
Study Completion Date2026-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Endometrial Cancer
  • Cervical Cancer
  • Atypical Endometrial Hyperplasia
  • Cervical Dysplasia
  • Adnexal Mass
  • Ovarian Cancer