Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
(ECHO Trial)
Recruiting at17 trial locations
JN
Overseen byJamie N Bakkum-Gamez, M.D.
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
No Placebo Group
Trial Summary
What is the purpose of 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 tampon-collected vaginal fluid and 2) ovarian cancer (OC) in plasma and tampon-collected 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.
Research Team
JN
Jamie N Bakkum-Gamez, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
Abnormal uterine bleeding
Postmenopausal bleeding
Treatment Details
Interventions
Blood Collection (Diagnostic Test)
Tampon Collection (Diagnostic Test)
Participant Groups
7Treatment groups
Experimental Treatment
Group I: Cohort 7 - OC Cohort - Biopsy proven or clinically suspected ovarian cancer (OC)Experimental Treatment2 Interventions
Women ≥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.
Group II: Cohort 6- Isolated Adnexal Mass Cohort (ovarian or fallopian mass)Experimental Treatment2 Interventions
Women ≥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 will have a final diagnosis of any of the following: benign ovarian neoplasm, borderline tumor of the ovary, or clinically early-stage OC.
Group III: Cohort 5 - Healthy Control WomenExperimental Treatment2 Interventions
Healthy women ≥45 years of age presenting for well-woman exams to serve as a control group. These women will have no clinically evident gynecologic precancers, gynecologic cancers, or clinically evident or symptomatic benign gynecologic conditions. These women 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.
Group IV: Cohort 4 - Benign Uterine PathologyExperimental Treatment2 Interventions
Women with any of four benign gynecologic conditions including: uterine fibroids, benign endometrial polyps, adenomyosis and endometriosis. All women 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.
Group V: Cohort 3 - Cervix pathologyExperimental Treatment2 Interventions
Women ≥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.
Group VI: Cohort 2 - Biopsy-proven EC or AEH or EINExperimental Treatment2 Interventions
Women ≥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.
Group VII: Cohort 1 - AUB / PMBExperimental Treatment2 Interventions
Women ≥45 years of age, presenting with abnormal uterine bleeding (AUB) or post-menopausal bleeding (PMB). These presenting symptoms clinically warrant evaluation such as an endometrial biopsy to assess for underlying endometrial cancer, endometrial hyperplasia or other endometrial pathology.