RecruitingNot Applicable

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

United States3,110 participantsStarted 2021-08-03

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia * Current biopsy-proven endometrial cancer or endometrial hyperplasia * Current biopsy-proven benign endometrial polyp * Endometrial biopsy/sampling within the preceding 1 month showing benign endometrium Inclusion Criteria for Cohort 2: Patients will be ≥18 years of age and meet at least one of the following criteria: * Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\&C, hysteroscopic resection * Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\&C, hysteroscopic resection, etc) Exclusion Criteria for Cohort 2: * Undergoing surgical procedure for recurrent or metastatic EC * Received preoper…

What they're measuring

Develop predictive models from a panel of EC-specific MDMs and validate their performance in identifying underlying EC and AEH within vaginal fluid in a larger, more diverse cohort.

Timeframe: 18 months

Develop predictive models from a panel of OC-specific MDMs and validate their performance in identifying underlying OC within vaginal fluid and plasma in a larger, more diverse cohort.

Timeframe: 18 months

Trial details

NCT IDNCT05051722

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Maureen A Lemens, BSN

507-293-1487 lemens.maureen@mayo.edu

View on ClinicalTrials.gov More Endometrial Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Develop predictive models from a panel of EC-specific MDMs and validate their performance in identifying underlying EC and AEH within vaginal fluid in a larger, more diverse cohort.

Timeframe: 18 months

Develop predictive models from a panel of OC-specific MDMs and validate their performance in identifying underlying OC within vaginal fluid and plasma in a larger, more diverse cohort.

Timeframe: 18 months