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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

Abnormal uterine bleeding

Postmenopausal bleeding

Abnormal uterine bleeding

One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vaginal Fluid Collection
  • Blood Collection

Treatment groups

3,110 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators