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Vaginal Fluid Collection for Detection of Endometrial Cancer

NCT06294886 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-03-07

No results posted yet for this study

Summary

The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).

The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN.

Conditions

Interventions

DIAGNOSTIC_TEST

Screening test to detect endometrial cancer and precancer

The device is designed to detect DNA biomarkers for cancer in cells shed from the lining of the uterus into vaginal fluid

Sponsors & Collaborators

  • Innovis LLC

    lead INDUSTRY

Principal Investigators

  • Gregg S Britt · Innovis LLC

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06294886 on ClinicalTrials.gov