Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical Study

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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)

⁃ 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)

⁃ Patients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:

• History of current abnormal cervical/endocervical Pap test for which the patient is presenting for colposcopy

• Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated

• Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)

⁃ Patients will be ≥45 years of age and should meet at least one of the following criteria:

• Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and/or clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.

• Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.

⁃ Patients with a uterus will be ≥45 years of age and should meet the following criteria:

• Presenting for GYN wellness exam, ± Pap test

• No change in medical conditions, new diagnoses, or new medications within the past 6 months

⁃ Patients ≥50 years of age and:

• Postmenopausal

• At least 1 intact ovary

• Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)

• Planned surgery for the adnexal mass

• For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\* (without prior tubal ligation/occlusion)

⁃ Women will be ≥18 years of age and meet the following criteria:

• Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any/all of the following: imaging showing adnexal and/or abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology

• Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy

• At least one intact ovary

• For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\* (without prior tubal ligation/occlusion)

Locations
United States
Arizona
Mayo Clinic
RECRUITING
Phoenix
Florida
Mayo Clinic
RECRUITING
Jacksonville
Genoma Research, Inc.
RECRUITING
Miami
My GYN Care
ACTIVE_NOT_RECRUITING
Miami
Signature Women's Healthcare, LLC
ACTIVE_NOT_RECRUITING
Pembroke Pines
Sarasota Memorial Health Care System
RECRUITING
Sarasota
Illinois
University of Chicago
RECRUITING
Chicago
Providea Health Partners, LLC
ACTIVE_NOT_RECRUITING
Evergreen Park
Louisiana
Ochsner Clinic Foundation
RECRUITING
New Orleans
Michigan
Valley OB-GYN Clinic
RECRUITING
Saginaw
Minnesota
Mayo Clinic
RECRUITING
Rochester
Mississippi
University of Mississippi Medical Center
NOT_YET_RECRUITING
Jackson
North Dakota
Altru Health System
RECRUITING
Grand Forks
New York
The Woman's Health Pavilion
RECRUITING
Howard Beach
The Woman's Health Pavilion
RECRUITING
Westbury
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Texas
Medical Colleagues of Texas, LLP
RECRUITING
Katy
Wisconsin
Mayo Clinic Health System - Northwest Wisconsin
RECRUITING
Eau Claire
Mayo Clinic Health System - Southwest Wisconsin
RECRUITING
La Crosse
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Maureen A Lemens, BSN
lemens.maureen@mayo.edu
507-293-1487
Backup
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2021-08-03
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 3110
Treatments
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.
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.
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.
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.
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.
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.
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.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov