Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery

Stanford University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Gynecologic Cancer Gynecologic Disease Gynecological Surgery Uterine Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: At time of gynecologic surgery

Secondary Outcomes

Molecular profiling of uterine lavage specimens

Analysis of RNA, DNA, or protein expression profiles in collected lavage fluid.

Time frame: At time of surgery

Detection of inflammatory biomarkers in uterine lavage

Measurement of cytokines or other markers associated with uterine immune status or pathology.