Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Uterine Lavage.
- Who it may be relevant to
- Registry conditions: Gynecologic Cancer, Gynecologic Disease, Gynecological Surgery, Uterine Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploring the Molecular and Cellular Composition of Uterine Lavage Specimens Collected at the Time of Gynecologic Surgery.
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.
Interventions
- Procedure Uterine Lavage
Saline is introduced into the uterine cavity and retrieved during surgery to collect cells and fluid for downstream molecular and cellular analyses.
Primary outcome measures
- Characterization of cellular composition in uterine lavage fluid [Time frame: At time of gynecologic surgery]
Secondary outcome measures (2)
- Molecular profiling of uterine lavage specimens [Time frame: At time of surgery]
- Detection of inflammatory biomarkers in uterine lavage [Time frame: At time of surgery]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Stanford University — Palo Alto
Identifiers
NCT: NCT07044505 · IRB-77882