Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hyperplasia

Endometrial Hyperplasia

Carcinoma

Endometrial Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Precancerous Conditions

Ovarian Cancer

Cervical Intraepithelial Neoplasia

Ovarian Epithelial Cancer

All Drugs and Chemicals

Hormones

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.

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.

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.

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.

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.

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.

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..

Tampon Collection

A blood sample will be collected from each participant prior to undergoing any exams or procedures.

Blood Collection

Maureen A Lemens, BSN

Clinical Trials Referral Office

Lexi P. Baughman, B.S.

Dakota M Hohenwalter, M.S.

Kristina A. Butler, M.D.

Jessica Hoag, CRC

Kaylee F. Hoffman, CRC

Christopher C DeStephano, M.D., MPH

Raelan Santos, CRC

Nancy Slay, CRC

Joyce R. Miller, M.D.

Karen V. Seetal Kihei, ARNP-BC

Laura Lucia, BHSc, CRC

Guillermo Lievano, D.O.

Itsel Cardenas, PhD, APRN

Pablo E Uribasterra, M.D.

Rachael Sanacore

Megan Swiger

Toni P Kilts, D.O.

Beverly J Long, M.D.

Katrina Cabrera

Veronika Sesari

Kathryn Mills, M.D.

Annette Briseno, M.A., CRC

Kenneth Finkelstein, D.O.

Tanya West-Hutchins, MSN, FNP-BC

Mackenzie Rittenberg, CCRC

Jacqueline Lang, CCRC

Olivia A. Phifer-Combs, M.D.

Jamie N Bakkum-Gamez, MD

Jennifer Barnes

Rodney Rocconi, M.D.

Monica Martinez, CRC

Andre H Saad, M.D.

Lorina Weymier

Tina Schmitz, BSN

Collette Lessard, M.D.

Tori Carpenter, CRC

Sarah Neale, CRC

Mariam AlHilli, M.D.

Huma Zafar

Kelly A McCullagh, M.D.

Jamie N Bakkum-Gamez, M.D.

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.

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.

* A sample of the vaginal fluid pool will be collected via a standard tampon from each study participant prior to any clinical exams or procedures.
* A peripheral blood sample will be collected from each study participant prior to any clinical exams or procedures.

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

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

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.

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.

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.

Mayo Clinic

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer	NCT05051722	Endometrial Can... Cervical Cancer Atypical Endome... Cervical Dyspla... Adnexal Mass Ovarian Cancer	Tampon Collecti... Blood Collectio...	18 Years -	Mayo Clinic
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer	NCT05051722	Endometrial Can... Cervical Cancer Atypical Endome... Cervical Dyspla... Adnexal Mass Ovarian Cancer	Tampon Collecti... Blood Collectio...	18 Years -	Mayo Clinic

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