Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery

NCT07044505 | Recruiting

• 1 other identifier: IRB-77882
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Gynecologic Disease; Gynecological Surgery; Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• Characterization of cellular composition in uterine lavage fluid

  Quantification and classification of cell types obtained from uterine lavage specimens using cytology and/or flow cytometry.

  At time of gynecologic surgery

Secondary Outcomes (2)

• Molecular profiling of uterine lavage specimens

  At time of surgery

• Detection of inflammatory biomarkers in uterine lavage

  At time of surgery

Study Arms (1)

Single Group

EXPERIMENTAL

Participants undergoing gynecologic surgery who agree to uterine lavage collection intraoperatively for molecular and cellular analysis.

Procedure: Uterine Lavage

Interventions

Uterine Lavage PROCEDURE

Saline is introduced into the uterine cavity and retrieved during surgery to collect cells and fluid for downstream molecular and cellular analyses.

Single Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases

Study Officials

• James Ford, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rozelle Laquindanum

CONTACT

(650) 724-9948; rlaquind@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)