Endometrial Cancer Vaginal Fluid Specimen Collection Study

Summary

This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.

Eligibility

Inclusion Criteria

Cohort 1 Participants:

* 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)

Cohort 2 Participants:

* Age ≥ 18 years
* Newly diagnosed, biopsy-confirmed EC or AEH/EIN
* Planning initial management for their endometrial pathology

Exclusion Criteria

* 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

Additional for Cohort 1:

* 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

Additional for Cohort 2:

* 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

Conditions6

Locations4 sites

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