Molecular and cellular analysis of uterine lavage from gynecologic surgery
Exploring the Molecular and Cellular Composition of Uterine Lavage Specimens Collected at the Time of Gynecologic Surgery.
This will try a new uterine lavage catheter to collect samples from up to 50 adults having gynecologic surgery to see what cells are present.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT07044505 on ClinicalTrials.gov |
What this trial studies
This is a prospective, consecutively-enrolled cohort of up to 50 adults undergoing gynecologic surgery at Stanford who will each have a uterine lavage sample collected with a novel catheter. The primary aim is to test the clinical and technical feasibility of collecting uterine lavage and to describe the molecular and cellular composition of the samples. Collected samples will undergo molecular and cellular profiling to characterize cell types and any disease-related signals. The procedure is performed intraoperatively and does not change the participant's planned surgical care.
Who should consider this trial
Good fit: Adults (18+) scheduled for gynecologic surgery at Stanford with an intact uterus and cervix, at least one intact fallopian tube and ovary on the same side, and the ability to provide informed consent.
Not a fit: People who are not having surgery at Stanford, who lack an intact uterus or cervix, have known endometrial or cervical cancer, have an IUD, are pregnant, or cannot consent are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could enable better, less invasive sampling of uterine and adnexal tissues to inform future diagnostics or research into gynecologic disease.
How similar studies have performed: Related uterine lavage and cytology research has produced promising sampling results, but intraoperative molecular and cellular profiling using this specific catheter is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Palo Alto, California
- Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: James Ford, MD — Stanford University
- Study coordinator: Rozelle Laquindanum
- Email: rlaquind@stanford.edu
- Phone: (650) 724-9948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.