NCT06294886

Vaginal Fluid Collection for Detection of Endometrial Cancer

Vaginal Fluid Collection Study for Endometrial Cancer Test Research and Development

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Innovis LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For participants providing written informed consent to participate in the study, samples of vaginal fluid will be obtained by the Principal Investigator (PI) during a pelvic examination. All vaginal fluid samples will be collected ≥7 days after the endometrial biopsy and prior to initiating any therapeutic interventions including surgery, chemotherapy, radiation or hormonal therapy PIs will be provided with multiple, individually packaged Copan eNat® sterile sample collection kits including a swab and a transport tube containing a stabilizer and preservative medium as well as a pre-addressed shipping container and single-use tubes of sterile saline solution After vaginal fluid sample collection, the swab will be inserted into the tube for storage and subsequent shipping to the Sponsor's designated laboratory. The samples can be stored at ambient temperature and should be shipped to the designated laboratory within 24 hours of collection. Site(s) will provide the Sponsor with de-identified endometrial biopsy histopathology report and post-surgery histopathology report (if any) confirming the histopathological diagnosis of EC, AEH or EIN. The final diagnosis will be based on the most severe clinical histopathology (at diagnostic endometrial sampling or surgery.)

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-19
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2024-03-06
• Last updated: 2024-03-07

Locations

1 site across 1 country: United States