Vaginal Fluid Collection Study to Detect Endometrial Cancer and Related Conditions

What this Trial Is About

Researchers are conducting a multicenter, prospective study to collect vaginal fluid specimens for the development and evaluation of tests aimed at detecting endometrial cancer, other cancers, or their causes. This observational study focuses on women undergoing clinical evaluation for abnormal uterine bleeding or those newly diagnosed with endometrial cancer or related conditions such as atypical endometrial hyperplasia or endometrial intraepithelial neoplasia. Participants are divided into two groups those being evaluated for abnormal uterine bleeding and planning standard tissue sampling, and those with a new biopsy-confirmed diagnosis of endometrial cancer or related conditions who are planning initial management. Vaginal fluid specimens and clinical data are collected within 90 days of enrollment to support biomarker assay development and evaluation. Various collection devices are also assessed to improve detection methods. During the study, participants provide vaginal fluid samples and relevant clinical information within 90 days of joining. Researchers analyze these specimens to characterize endometrial neoplasia, other neoplasms, or underlying causes. The study does not involve treatment but focuses on gathering data to advance detection tests. Participation duration and follow-up are limited to the specimen collection and data gathering period within the initial 90 days.

Endometrial Cancer Vaginal Fluid Specimen Collection Study