Endometrial Cancer Vaginal Fluid Specimen Collection Study

This study is collecting vaginal fluid samples to help develop and test new ways to detect endometrial cancer and other related conditions. Researchers are looking for women aged 18 and older who have abnormal uterine bleeding (AUB) and are already planning to have a standard procedure to check for endometrial cancer or atypical endometrial hyperplasia (pre-cancerous changes in the uterine lining). The goal is to gather enough samples and clinical information to create better detection tools. The study aims to enroll 4200 participants. The study's success will be measured by collecting these samples and related clinical data within 90 days of you joining.

Study design: This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 4200 participants.
What's involved: You would provide vaginal fluid specimens and clinical data. This collection would happen within 90 days of joining the study.
Compensation: Not stated in the trial record.
Follow-up: Your participation involves specimen and data collection within 90 days of enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Endometrial Cancer Vaginal Fluid Specimen Collection Study

Recruiting

Not specifiedAges 18+Observational

Exact Sciences Corporation

~4,200 participants

Updated 2026-08-27 on ClinicalTrials.gov

At a glance

Recruiting sites

5 of 5 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Collection of clinically characterized vaginal fluid specimens

Measured over Within 90 days of enrollment.

+3 more outcomes measured

Conditions

Abnormal Uterine Bleeding (AUB)

Endometrial Cancer

Atypical Endometrial Hyperplasia

Endometrial Hyperplasia With Atypia

Endometrial Intraepithelial Neoplasia

Where it's being run

5 sites across 4 states

Tennessee2

Florida1

Maine1

Texas1

Who to contact

Clinical Trial Manager

[email protected]

608-982-1588

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 45 years, OR age ≥ 18 years with at least one risk factor

Diagnosed with abnormal uterine bleeding (AUB)

Planning standard-of-care endometrial tissue sampling to assess for endometrial cancer (EC) or atypical endometrial hyperplasia/endometrial intraepithelial neoplasia (AEH/EIN)

Age ≥ 18 years

Newly diagnosed, biopsy-confirmed EC or AEH/EIN

Planning initial management for their endometrial pathology

Exclusion

Prior partial or complete hysterectomy

Current pregnancy

Prior pelvic or vaginal radiotherapy

Chemotherapy within past 5 years (except tamoxifen)

Any condition judged by the Investigator to preclude participation

Cancer diagnosis within past 5 years (except non-gynecologic skin cancer)

Current biopsy-proven cervical, vaginal, or vulvar cancer, or lower genital tract dysplasia

Current biopsy-proven endometrial cancer, hyperplasia, or benign polyp

Benign endometrial biopsy within last month

Cancer diagnosis other than EC within past 5 years (except non-gynecologic skin cancer)

Prior cervical cancer or biopsy-proven cervical dysplasia

Surgery for recurrent EC

Preoperative neoadjuvant chemotherapy or radiotherapy for current EC

Prior treatment or surgery to remove target pathology during current episode

What this trial measures

Collection of clinically characterized vaginal fluid specimensWithin 90 days of enrollment.
Vaginal fluid specimens will be collected during a standard clinical exam using a swab-based collection method. Specimens will be used for research purposes to support the development of biomarker assays. No specific biomarkers or analytical methods are defined as part of this study.
Clinical data for biomarker assay development and evaluationWithin 90 days of enrollment
Clinical information will be collected as part of routine study participation and used to describe the study population and support research analyses. Data will be used in aggregate to contextualize research findings and inform future assay development.
Collection devices for detectionWithin 90 days of enrollment
Specimens will be collected using swab-based collection devices intended solely for specimen collection. These devices do not provide diagnostic results and are not used for clinical decision-making.
Characterization of endometrial neoplasia, other neoplasms, or underlying causesWithin 90 days of enrollment
Characterization will be based on existing clinical assessments and diagnoses obtained through standard medical care. The study does not establish diagnostic criteria or endpoints and is intended for research and development purposes only.

Trialytics