Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery

Not Applicable

Not yet recruiting

• Conditions: Gynecologic Cancer; Gynecologic Disease; Gynecological Surgery; Uterine Cancer

• Registration Number: NCT07044505
• Lead Sponsor: Stanford University

Brief Summary

This study is a designed as a to test the clinical and technical feasibility of using this novel uterine lavage collection catheter to collected UL samples from up to 50 individuals undergoing gynecologic surgery and to describe the cellular composition of these samples. In order to do this, it is a prospective consecutively-enrolled cohort of 50 participants, all of who will receive the intervention of uterine lavage collection.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Study Start: 2025-09-01
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Undergoing gynecologic surgery with Stanford Healthcare
• Intact uterus and cervix
• At least one intact fallopian tube and ovary (on the same side)
• Aged 18 years or older
• Ability to understand and the willingness to provide written informed consent.

Exclusion Criteria

• Known endometrial or cervical cancer or endometrial or cervical intraepithelial neoplasia
• Status post bilateral salpingectomy or tubal ligation
• Lack of consenting capacity
• Positive preoperative pregnancy test
• Active uterine bleeding (i.e. menses, etc.)
• Intrauterine device in place
• Non-English speaking (requires interpretor)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Characterization of cellular composition in uterine lavage fluid	At time of gynecologic surgery	Quantification and classification of cell types obtained from uterine lavage specimens using cytology and/or flow cytometry.

Secondary Outcome Measures

Name	Time	Method
Molecular profiling of uterine lavage specimens	At time of surgery	Analysis of RNA, DNA, or protein expression profiles in collected lavage fluid.
Detection of inflammatory biomarkers in uterine lavage	At time of surgery	Measurement of cytokines or other markers associated with uterine immune status or pathology.