Gynecological Surgery, Gynecologic Cancer, Gynecologic Disease, Uterine Cancer
Conditions
Brief summary
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
PROCEDUREUterine Lavage
Saline is introduced into the uterine cavity and retrieved during surgery to collect cells and fluid for downstream molecular and cellular analyses.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of cellular composition in uterine lavage fluid | At time of gynecologic surgery | Quantification and classification of cell types obtained from uterine lavage specimens using cytology and/or flow cytometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Molecular profiling of uterine lavage specimens | At time of surgery | Analysis of RNA, DNA, or protein expression profiles in collected lavage fluid. |
| Detection of inflammatory biomarkers in uterine lavage | At time of surgery | Measurement of cytokines or other markers associated with uterine immune status or pathology. |
Countries
United States
Contacts
Primary ContactRozelle Laquindanum
Outcome results
None listed