Endometrial Cancer Vaginal Fluid Specimen Collection Study

What this trial studies

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

Conditions in scope

• Abnormal Uterine Bleeding (AUB)
• Endometrial Cancer
• Atypical Endometrial Hyperplasia
• Endometrial Hyperplasia With Atypia
• Endometrial Intraepithelial Neoplasia

Interventions

• Not specified in the public record.

Who can join

Women only · Ages 18 Years and up

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2026-03-10
• Primary completion: 2028-04-24
• Last update posted: 2026-04-22
• First posted: 2026-04-22

Sponsor & contact

Lead sponsor: Exact Sciences Corporation (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Collection of clinically characterized vaginal fluid specimens (Within 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 evaluation (Within 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 detection (Within 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 causes (Within 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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.