- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05051722
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer (ECHO)
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Detection of endometrial, ovarian, and cervical cancers at an early stage vastly increases the chances of cure and may also avert morbidity secondary to surgical staging, radiation, and/or chemotherapy. Despite the great successes of cervical cancer screening, comparable early detection methods for other gynecologic cancers and their precursors are not available. While nearly 1.5 million women per year in the United States are evaluated for abnormal uterine bleeding (AUB) or postmenopausal bleeding (PMB), the most common symptom of endometrial cancer, most undergo an invasive diagnostic biopsy with the finding of benign etiology.
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maureen A Lemens, BSN
- Phone Number: 507-293-1487
- Email: lemens.maureen@mayo.edu
Study Contact Backup
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
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Florida
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Jacksonville, Florida, United States, 32224
- Recruiting
- Mayo Clinic
-
Principal Investigator:
- Christopher C DeStephano, M.D., MPH
-
Contact:
- Jessica Hoag, CRC
- Email: hoag.jessica@mayo.edu
-
Contact:
- Kaylee F. Hoffman, CRC
- Email: hoffman.kaylee@mayo.edu
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Miami, Florida, United States, 33173
- Recruiting
- Genoma Research, Inc.
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Contact:
- Laura Lucia, BHSc, CRC
- Phone Number: 305-392-1264
- Email: lauralucia@genoma.comcastbiz.net
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Principal Investigator:
- Guillermo Lievano, D.O.
-
Sub-Investigator:
- Itsel Cardenas, PhD, APRN
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Miami, Florida, United States, 33156
- Recruiting
- My GYN Care
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Contact:
- Raelan Santos, CRC
- Phone Number: 561-614-6080
- Email: Raelan.Santos@elligodirect.com
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Contact:
- Nancy Slay, CRC
- Email: Nancy.Slay@elligodirect.com
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Principal Investigator:
- Joyce R. Miller, M.D.
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Sub-Investigator:
- Karen V. Seetal Kihei, ARNP-BC
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Pembroke Pines, Florida, United States, 33029
- Recruiting
- Signature Women's Healthcare, LLC
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Contact:
- Nancy Slay, CRC
- Email: Nancy.Slay@elligodirect.com
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Contact:
- Raelan Santos, CRC
- Phone Number: 954-447-1446
- Email: Raelan.Santos@elligodirect.com
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Principal Investigator:
- Pablo E Uribasterra, M.D.
-
Sarasota, Florida, United States, 34239
- Recruiting
- Sarasota Memorial Health Care System
-
Contact:
- Rachael Sanacore
- Email: Rachael-Sanacore@smh.com
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Contact:
- Megan Swiger
- Email: Megan-Swiger@smh.com
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Principal Investigator:
- Toni P Kilts, D.O.
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Sub-Investigator:
- Beverly J Long, M.D.
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
-
Contact:
- Katrina Cabrera
- Phone Number: 773-834-6413
- Email: kcabrera1@bsd.uchicago.edu
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Contact:
- Veronika Sesari
- Email: vseseri@bsd.uchicago.edu
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Principal Investigator:
- Kathryn Mills, M.D.
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Evergreen Park, Illinois, United States, 60805
- Recruiting
- Providea Health Partners, LLC
-
Contact:
- Annette Briseno, M.A., CRC
- Phone Number: 708-571-2901
- Email: annette.briseno@elligodirect.com
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Principal Investigator:
- Kenneth Finkelstein, D.O.
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Sub-Investigator:
- Tanya West-Hutchins, MSN, FNP-BC
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Michigan
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Saginaw, Michigan, United States, 48602
- Recruiting
- Valley OB-GYN Clinic
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Contact:
- Mackenzie Rittenberg, CCRC
- Phone Number: 989-899-7263
- Email: mackenzie.rittenberg@elligodirect.com
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Contact:
- Jacqueline Lang, CCRC
- Phone Number: 989-272-9065
- Email: jacqueline.lang@elligodirect.com
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Principal Investigator:
- Olivia A. Phifer-Combs, M.D.
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
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Contact:
- Maureen A Lemens, BSN
- Phone Number: 507-293-1487
- Email: lemens.maureen@mayo.edu
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Principal Investigator:
- Jamie N Bakkum-Gamez, MD
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New York
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Howard Beach, New York, United States, 11414
- Recruiting
- The Woman's Health Pavilion
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Contact:
- Monica Martinez, CRC
- Phone Number: 718-843-6300
- Email: mmartinez@ilovemygyn.com
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Principal Investigator:
- Andre H Saad, M.D.
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North Dakota
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Grand Forks, North Dakota, United States, 58206
- Recruiting
- Altru Health System
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Contact:
- Lorina Weymier
- Email: lweymier@altru.org
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Contact:
- Tina Schmitz, BSN
- Phone Number: 701-780-1845
- Email: tkschmitz@altru.org
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Principal Investigator:
- Collette Lessard, M.D.
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Texas
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Katy, Texas, United States, 77450
- Recruiting
- Medical Colleagues of Texas, LLP
-
Contact:
- Huma Zafar
- Phone Number: 281-768-4943
- Email: Huma.Zafar@elligodirect.com
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Principal Investigator:
- Kelly A McCullagh, M.D.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria for Cohort 1:
Women will be ≥45 years of age and meet at least one of the following criteria:
- Abnormal uterine bleeding
- Postmenopausal bleeding
Exclusion Criteria for Cohort 1:
- 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
- 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
Inclusion Criteria for Cohort 2:
Women 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)
Exclusion Criteria for Cohort 2:
- Undergoing surgical procedure for recurrent or metastatic EC
- Receipt of 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
Inclusion Criteria for Cohort 3:
Women 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)
Exclusion Criteria for Cohort 3:
- 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
Inclusion Criteria for Cohort 4:
Women 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.
Exclusion Criteria for Cohort 4:
- 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
Inclusion Criteria for Cohort 5:
Women will be ≥45 years of age and should meet the following criteria:
- Presenting for well-woman exam, ± Pap test
- No change in medical conditions, new diagnoses, or new medications within the past 6 months;
Exclusion Criteria for Cohort 5:
- 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
Inclusion Criteria for Cohort 6:
Women ≥50 years of age and:
- Postmenopausal status
- 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 tampon collection, patient must have a uterus, cervix and at least 1 intact fallopian tube* (without prior tubal ligation/occlusion)
Exclusion criteria - Isolated Adnexal Mass cohort: (Cohort 6)
- 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
Inclusion criteria - OC Cohort: (Cohort 7)
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 tampon collection, patient must have a uterus, cervix and at least 1 intact fallopian tube* (without prior tubal ligation/occlusion)
Exclusion criteria - OC Cohort (Cohort 7):
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort 1 - AUB / PMB
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.
|
A tampon will be self-inserted by each participant prior to any exams or procedures and removed after 40 minutes..
Other Names:
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
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.
|
A tampon will be self-inserted by each participant prior to any exams or procedures and removed after 40 minutes..
Other Names:
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
|
Cohort 3 - Cervix pathology
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.
|
A tampon will be self-inserted by each participant prior to any exams or procedures and removed after 40 minutes..
Other Names:
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
|
Cohort 4 - Benign Uterine Pathology
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.
|
A tampon will be self-inserted by each participant prior to any exams or procedures and removed after 40 minutes..
Other Names:
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
|
Cohort 5 - Healthy Control Women
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.
|
A tampon will be self-inserted by each participant prior to any exams or procedures and removed after 40 minutes..
Other Names:
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)
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.
|
A tampon will be self-inserted by each participant prior to any exams or procedures and removed after 40 minutes..
Other Names:
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)
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.
|
A tampon will be self-inserted by each participant prior to any exams or procedures and removed after 40 minutes..
Other Names:
A blood sample will be collected from each participant prior to undergoing any exams or procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Develop predictive models from a panel of EC-specific MDMs and validate their performance in identifying underlying EC and AEH within tampon-collected vaginal fluid in a larger, more diverse cohort.
Time Frame: 18 months
|
Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based endometrial cancer detection test performed on vaginal fluid collected via intravaginal tampon.
The phase II aspect of this biomarker development study will narrow the number of endometrial cancer MDMs within the biomarker panel in order to optimize the next phase of test development.
|
18 months
|
Develop predictive models from a panel of OC-specific MDMs and validate their performance in identifying underlying OC within tampon-collected vaginal fluid and plasma in a larger, more diverse cohort.
Time Frame: 18 months
|
Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based ovarian cancer detection test performed on vaginal fluid collected via intravaginal tampon.
The phase II aspect of this biomarker development study will narrow the number of ovarian cancer MDMs within the biomarker panel in order to optimize the next phase of test development.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Using 95% specificity cutoffs of the final tampon-based MDM EC panel, determine the false positive rate among women undergoing surgical removal of common benign gynecologic pathology
Time Frame: 18 months
|
As part of this biomarker test development, understanding whether common non-cancerous uterine or gynecologic conditions may also lead to the finding of currently apparent endometrial cancer-specific MDMs in vaginal fluid is critical in determining specificity, positive predictive value, and negative predictive value of the test.
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jamie N Bakkum-Gamez, M.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Precancerous Conditions
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Hyperplasia
- Ovarian Neoplasms
- Endometrial Hyperplasia
- Endometrial Neoplasms
- Carcinoma, Ovarian Epithelial
- Uterine Cervical Dysplasia
Other Study ID Numbers
- 20-012833
- NCI-2022-10826 (Registry Identifier: NCI)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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