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RECRUITING

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

NCT05051722 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Mayo Clinic

3,246 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05051722

The ClinicalTrials.gov registry entry for NCT05051722 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05051722 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05051722?

The interventions under investigation include: Vaginal Fluid Collection (DIAGNOSTIC_TEST), Blood Collection (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05051722?

This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial