Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Uterine Lavage
Procedure/SurgerySaline is introduced into the uterine cavity and retrieved during surgery to collect cells and fluid for downstream molecular and cellular analyses.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Single GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
Molecular profiling of uterine lavage specimens
Analysis of RNA, DNA, or protein expression profiles in collected lavage fluid.
Time frame
At time of surgery2
Detection of inflammatory biomarkers in uterine lavage
Measurement of cytokines or other markers associated with uterine immune status or pathology.
Time frame
At time of surgerySponsors and contacts
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Source ClinicalTrials.gov