NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Endometrial Cancer Vaginal Fluid Specimen Collection Study

RecruitingN/A

Sponsor: Exact Sciences Corporation

Conditions: Abnormal Uterine Bleeding (AUB), Endometrial Cancer, Atypical Endometrial Hyperplasia, Endometrial Hyperplasia With Atypia, Endometrial Intraepithelial Neoplasia

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (5)

Sarasota, Florida, United States
Scarborough, Maine, United States
Murfreesboro, Tennessee, United States
Murfreesboro, Tennessee, United States
Frisco, Texas, United States