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NCT05051722 · ClinicalTrials.gov registry record

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

A clinical trial of Ovarian Cancer and Endometrial Cancer, sponsored by Mayo Clinic.

Recruiting
Registry status
3,110
Enrollment target
20
Study locations

NCT05051722: Recruiting study of Ovarian Cancer and Endometrial Cancer, sponsored by Mayo Clinic.

NCT05051722 is a study of Ovarian Cancer and Endometrial Cancer that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 3,110 participants, above the 719-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (333% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05051722, a study of Ovarian Cancer and Endometrial Cancer, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
3,110 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based endometrial cancer detection test performed on vaginal fluid. The phase II aspect of this biomarker development study will narrow the number of endometrial cancer MDMs within the biomarker panel in order to optimize the next phase of test development.

Conditions Studied

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

Interventions

  • DIAGNOSTIC_TEST Vaginal Fluid Collection
  • DIAGNOSTIC_TEST Blood Collection

Study Locations (20)

Florida

  • Mayo Clinic - Jacksonville
  • My GYN Care - Miami
  • Genoma Research, Inc. - Miami
  • Orlando Health - Orlando
  • Signature Women's Healthcare, LLC - Pembroke Pines
  • Sarasota Memorial Health Care System - Sarasota

Illinois

  • University of Chicago - Chicago
  • Providea Health Partners, LLC - Evergreen Park

New York

  • The Woman's Health Pavilion - Howard Beach
  • The Woman's Health Pavilion - Westbury

Texas

  • Total Women's Care of the Heights - Houston
  • Medical Colleagues of Texas, LLP - Katy

Arizona

  • Mayo Clinic - Phoenix

Georgia

  • Piedmont Healthcare - Atlanta

Louisiana

  • Ochsner Clinic Foundation - New Orleans

Michigan

  • Valley OB-GYN Clinic - Saginaw

Trial Details

FieldValue
Enrollment Target 3,110 participants
Start Date 2021-08-03
Est. Completion 2027-06-30
Mayo Clinic

2,844 total trials

What NCT05051722 shows while recruiting

NCT05051722 is an observational study that tracks outcomes without assigning an intervention. Its 3,110 participants enrollment target places it among the larger protocols in the corpus, above the 719-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (333% higher).

The record links to 6 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Vaginal Fluid Collection is the first listed.

NCT05051722 names 20 study sites across 12 states, led by Florida, Illinois, New York.

Frequently Asked Questions

What is clinical trial NCT05051722 about?

NCT05051722 is a clinical study titled "Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer". 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 prop...

What is the current status of trial NCT05051722?

This trial is currently recruiting. The enrollment target is 3,110 participants. The study started on 2021-08-03. Estimated completion is 2027-06-30.

What conditions does trial NCT05051722 study?

This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Cervical Dysplasia, Atypical Endometrial Hyperplasia.

What interventions are being tested in trial NCT05051722?

The interventions under investigation include: Vaginal Fluid Collection (DIAGNOSTIC_TEST), Blood Collection (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05051722?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05051722 being conducted?

This trial has 20 study locations across Arizona, Florida, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Ovarian Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05051722's enrollment target sits among peer trials

3,110 11th of 322 higher than 312 of 322 other Ovarian Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05051722

Source: ClinicalTrials.gov NCT05051722, the US trial registry maintained by the National Library of Medicine. NCT05051722 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.