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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vaginal Fluid Collection — DIAGNOSTIC_TEST
  A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.
• Blood Collection — DIAGNOSTIC_TEST
  A blood sample will be collected from each participant prior to undergoing any exams or procedures.

Study Details

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.

Key Dates

Start date

Aug 3, 2021

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

3,110 participants (estimated)

Arms

• Arm: Cohort 1 - AUB / PMB
  Patients ≥45 years of age, presenting with abnormal uterine bleeding (AUB) or post-menopausal bleeding (PMB). Patients ages 18 - 44 years of age, presenting with abnormal uterine bleeding (AUB) and a risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use). These presenting symptoms clinically warrant evaluation such as an endometrial biopsy to assess for underlying endometrial cancer, endometrial hyperplasia or other endometrial pathology.
• Arm: Cohort 2 - Biopsy-proven EC or AEH or EIN
  Patients ≥18 years of age with biopsy-proven endometrial cancer (EC), atypical endometrial hyperplasia (AEH), or endometrial intraepithelial neoplasia (EIN) presenting for surgical management of their endometrial pathology.
• Arm: Cohort 3 - Cervix pathology
  Patients ≥18 years of age presenting for a clinically indicated colposcopy, cervical biopsy, or surgical excision, as follow-up for an abnormal Pap test or cervical mass identified on physical exam. Final clinical diagnoses within this cohort may include mild cervical intraepithelial neoplasia (CIN 1), moderate and/or severe CIN (CIN 2/3), adenocarcinoma in situ (AIS), invasive cervical cancers (adenocarcinoma or squamous cell carcinoma), or possibly benign findings.
• Arm: Cohort 4 - Benign Uterine Pathology
  Patients with any of four benign gynecologic conditions including: uterine fibroids, benign endometrial polyps, adenomyosis and endometriosis. All patients enrolled in this cohort will be undergoing clinically indicated gynecologic surgery (hysterectomy, myomectomy, polypectomy, or laparoscopic tissue excision) for the specific benign gynecologic condition. Verification of the final benign diagnosis will be based on pathology diagnosis of clinically-indicated tissue removed during surgery.
• Arm: Cohort 5 - Healthy Control Women
  Healthy patients with a uterus, ≥45 years of age presenting for GYN wellness exam to serve as a control group. These patients will have no clinically evident gynecologic precancers, gynecologic cancers, or clinically evident or symptomatic benign gynecologic conditions. These patients will not have known or clinically suspected AUB, PMB, fibroids, endometriosis, benign endometrial polyps, or adenomyosis, nor will they have any active gynecologic or non-gynecologic acute medical conditions.
• Arm: Cohort 6- Isolated Adnexal Mass Cohort (ovarian or fallopian mass)
  Patients ≥50 years of age and postmenopausal (12 months since LMP or available blood hormone levels confirming postmenopausal status) and an isolated adnexal mass or isolated bilateral adnexal masses being surgically removed. These patients may have a final diagnosis of any of the following: benign ovarian neoplasm, borderline tumor of the ovary, or clinically early-stage OC.
• Arm: Cohort 7 - OC Cohort - Biopsy proven or clinically suspected ovarian cancer (OC)
  Patients ≥18 years of age with ovarian cancer (OC) (clinically probable based on distribution of pelvic/abdominal masses on imaging, elevated CA-125, ascites, and/or imaging-guided biopsy proven) presenting for neoadjuvant chemotherapy or primary surgical management (debulking or staging) of their OC. The umbrella of OC also includes fallopian tube cancer and primary peritoneal cancer. All histologies are eligible for enrollment.

Primary Outcome Measure

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. [ Time Frame: 18 months ]

Central Contacts

• Maureen A Lemens, BSN
  507-293-1487
  [email protected]
• Clinical Trials Referral Office
  855-776-0015
  [email protected]

Locations (24)

Find similar trials in Phoenix, AZ

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