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NCT Number: NCT07044505

Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery

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.

Recruiting

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Key information

Conditions

Gynecologic Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gynecologic Disease Gynecological Surgery Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

James Ford, MD

PRINCIPAL_INVESTIGATOR

Rozelle Laquindanum

CONTACT

[email protected]

650-724-9948

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Characterization of cellular composition in uterine lavage fluid

    Time frame: At time of gynecologic surgery

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

Secondary outcomes

  1. Molecular profiling of uterine lavage specimens

    Time frame: At time of surgery

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

  2. Detection of inflammatory biomarkers in uterine lavage

    Time frame: At time of surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rozelle Laquindanum

CONTACT

[email protected]

(650) 724-9948

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Exploring the Molecular and Cellular Composition of Uterine Lavage Specimens Collected at the Time of Gynecologic Surgery.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2025
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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