Upcoming Endometrial Cancer Research Study

This endometrial cancer research study is a prospective, specimen-collection-only trial. This means participants are not testing a new drug or treatment; rather, they are contributing biological samples that allow scientists to study how specific biomarkers appear in vaginal fluid.

Researchers are developing a novel assay to detect biomarkers associated with endometrial cancer (EC) and precancerous lesions, such as atypical endometrial hyperplasia (AEH) or endometrial intraepithelial neoplasia (EIN). By participating, you provide the “real-world” samples necessary to validate these diagnostic tools. The study is being conducted at multiple clinical sites across the United States.

It is important to note that there are no direct medical benefits to participants in this endometrial cancer research study. The results of the specimen testing will not be used for your individual treatment or health management, and results are not shared with your doctors.

However, your contribution is essential for:

• Advancing Science: Helping researchers understand the biomarkers of gynecologic cancers.
• Future Patients: Supporting the development of non-invasive tests that could help other women avoid more painful diagnostic procedures in the future.
• Medical Innovation: Providing high-quality clinical data that drives the next generation of diagnostic technology.

To ensure the data is scientifically valid, the study has specific inclusion and exclusion criteria. Participants are generally divided into two cohorts:

Inclusion Criteria

Cohort 1 (Symptomatic Participants):

• Must be at least 45 years of age experiencing abnormal uterine bleeding (AUB).

• Alternatively, aged 18+ with at least one risk factor (BMI ≥ 30 kg/m², PCOS diagnosis, or history of tamoxifen use) and experiencing AUB.

• Planning to undergo standard-of-care endometrial tissue sampling (like a biopsy).

Cohort 2 (Confirmed Diagnosis Participants):

• At least 18 years of age.

• Newly diagnosed, biopsy-proven endometrial cancer or AEH/EIN.

• Planning to undergo initial surgical management for their condition.

Exclusion Criteria

You may not be eligible if you meet any of the following:

• Prior partial or complete hysterectomy.

• Current pregnancy.

• Previous pelvic or vaginal radiotherapy.

• Chemotherapy for cancer within the past 5 years (excluding tamoxifen).

Not sure if you qualify?

A member of our study team will review your medical history and medications with you to determine if this endometrial cancer research study may be a good fit for you. You may also qualify for other studies.

If you choose to participate in our endometrial cancer research study, your involvement will be integrated into your existing medical appointments to minimize inconvenience.

Study Duration

Active participation is completed once all requested specimens are collected and your standard surgical or sampling procedures are finished. For both cohorts, specimen collection and the related medical procedure must occur within 90 days of your enrollment.

Study Procedures and Visits

• Vaginal Swabs: A healthcare provider will collect vaginal fluid using three swabs during a standard speculum exam. This is non-invasive and does not enter the uterus.

• Blood Collection: If requested by the sponsor, you may be asked to provide a blood sample (up to 55 mL) during your enrollment visit.

• Data Collection: Researchers will collect relevant medical history and copies of your pathology, surgical, and imaging reports.

• Tokenization: The study may use “data tokens” to link your de-identified information with real-world health records for long-term research.

Compensation

While the protocol does not list a specific universal compensation amount, many clinical sites offer reimbursement for time and travel. Our local study coordinator to see what is available at your specific location.

Need More Details? 

The study team will explain all procedures, site visits, and other requirements in detail before you decide to participate in our endometrial cancer research study.