Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery

NCT ID: NCT07044505

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-19

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Gynecologic Cancer Gynecologic Disease Gynecological Surgery Uterine Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single Group

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

Group Type EXPERIMENTAL

Uterine Lavage

Intervention Type PROCEDURE

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

Interventions

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Uterine Lavage

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Ford, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rozelle Laquindanum

Role: CONTACT

(650) 724-9948

Facility Contacts

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Rozelle Laquindanum

Role: primary

650-724-9948

Other Identifiers

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IRB-77882

Identifier Type: -

Identifier Source: org_study_id

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