Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
NCT ID: NCT05051722
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3110 participants
OBSERVATIONAL
2021-08-03
2027-06-30
Brief Summary
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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.
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Detailed Description
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Vaginal bleeding is often the only presenting symptom of women ultimately diagnosed with endometrial cancer (EC) or its precursor lesion, endometrial hyperplasia(EH). More than 90% of women with EC present with vaginal bleeding. Cervical cancer and cervical dysplasia can present as intermenstrual bleeding, post-coital bleeding, or other abnormal vaginal bleeding. However, most women who present with AUB or PMB have a benign etiology.
There are approximately 70 million women ≥45 years of age in the United States based on the most recent census data. Between 4-11% of women will be worked up for perimenopausal AUB or PMB in their lifetime. As only 5-10% of those women will have an EC or EH, there is a great clinical need for a less invasive clinical diagnostic test that can reliably distinguish between benign uterine bleeding and bleeding associated with an underlying endometrial cancer, cervical cancer, or a precursor lesion.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Vaginal Fluid Collection
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
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
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.
Vaginal Fluid Collection
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
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
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.
Vaginal Fluid Collection
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
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
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.
Vaginal Fluid Collection
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
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
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.
Vaginal Fluid Collection
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
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
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.
Vaginal Fluid Collection
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
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
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.
Vaginal Fluid Collection
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
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Interventions
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Vaginal Fluid Collection
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
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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)
Exclusion Criteria
* Current known pregnancy diagnosis
* Any prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia
* Current biopsy-proven endometrial cancer or endometrial hyperplasia
* Current biopsy-proven benign endometrial polyp
* Endometrial biopsy/sampling within the preceding 1 month showing benign endometrium
* Undergoing surgical procedure for recurrent or metastatic EC
* Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis
* Prior hysterectomy
* Current known pregnancy diagnosis
* Prior or current biopsy-proven cervical cancer
* Presence of concomitant biopsy-proven cervical dysplasia
* Any prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Prior intervention or surgery with intent to completely remove the target pathology
* History of pelvic or vaginal radiotherapy
* Prior total hysterectomy (cervix removed) for any indication
* Current known pregnancy diagnosis
* Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass
* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode
* Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis
* Any surgery within the past 3 months
* Prior hysterectomy
* Current known pregnancy diagnosis
* Prior or current biopsy-proven gynecologic cancer
* Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
* Prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis
* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode
* Pap test or cervical biopsy within the past 1 month
* Endometrial biopsy or office hysteroscopy within the past 1 month
* Any surgery within the past 3 months
* Prior hysterectomy
* Current known pregnancy diagnosis
* Prior or current biopsy-proven gynecologic cancer
* Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
* Prior pelvic or vaginal radiotherapy
* Any prior cancer (except basal cell skin cancer) within the past 5 years
* Chemotherapy within the past 5 years
* Criteria met for inclusion in any of the other study cohorts
* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)
* Chemotherapy for cancer treatment within the past 5 years prior to collection
* Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection
* Surgical candidates for recurrent ovarian cancer
* History of pelvic or vaginal radiation therapy
* Known current synchronous endometrial cancer or hyperplasia
* Known current cervical, vaginal, or vulvar dysplasia
* Patients with recurrent OC
* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years
* Chemotherapy for cancer treatment within the past 5 years prior to collection
* History of pelvic or vaginal radiation therapy
* Known current synchronous endometrial cancer or hyperplasia
* Known current cervical, vaginal, or vulvar dysplasia
* Current known pregnancy diagnosis
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Jamie N Bakkum-Gamez, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
My GYN Care
Miami, Florida, United States
Genoma Research, Inc.
Miami, Florida, United States
Orlando Health
Orlando, Florida, United States
Signature Women's Healthcare, LLC
Pembroke Pines, Florida, United States
Sarasota Memorial Health Care System
Sarasota, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Providea Health Partners, LLC
Evergreen Park, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Valley OB-GYN Clinic
Saginaw, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
The Woman's Health Pavilion
Howard Beach, New York, United States
The Woman's Health Pavilion
Westbury, New York, United States
Altru Health System
Grand Forks, North Dakota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Total Women's Care of the Heights
Houston, Texas, United States
Medical Colleagues of Texas, LLP
Katy, Texas, United States
Virginia Commonwealth University/ Massey Cancer Center
Richmond, Virginia, United States
Mayo Clinic Health System - Northwest Wisconsin
Eau Claire, Wisconsin, United States
Mayo Clinic Health System - Southwest Wisconsin
La Crosse, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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M
Role: backup
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2022-10826
Identifier Type: REGISTRY
Identifier Source: secondary_id
20-012833
Identifier Type: -
Identifier Source: org_study_id
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