[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07044505":3,"trial-entities:NCT07044505":97,"trial-summary:NCT07044505":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":50,"minimum_age":51,"maximum_age":15,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":69,"locations":72,"central_contacts":90,"overall_officials":93,"references":95,"see_also_links":96},"NCT07044505","IRB-77882","Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery","Exploring the Molecular and Cellular Composition of Uterine Lavage Specimens Collected at the Time of Gynecologic Surgery.","RECRUITING","2026-12","2025-11","2025-11-05","2025-09-19","Stanford University","OTHER",null,"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.",[18,19,20,21],"Gynecologic Cancer","Gynecologic Disease","Gynecological Surgery","Uterine Cancer",[],"INTERVENTIONAL","BASIC_SCIENCE",[26],"NA",{"count":28,"type":29},50,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"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.",[36],"Single Group",[38],{"measure":39,"description":40,"timeFrame":41},"Characterization of cellular composition in uterine lavage fluid","Quantification and classification of cell types obtained from uterine lavage specimens using cytology and\u002For flow cytometry.","At time of gynecologic surgery",[43,47],{"measure":44,"description":45,"timeFrame":46},"Molecular profiling of uterine lavage specimens","Analysis of RNA, DNA, or protein expression profiles in collected lavage fluid.","At time of surgery",{"measure":48,"description":49,"timeFrame":46},"Detection of inflammatory biomarkers in uterine lavage","Measurement of cytokines or other markers associated with uterine immune status or pathology.","ALL","18 Years",false,{"inclusion":54,"exclusion":60,"raw_text":68},[55,56,57,58,59],"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.",[61,62,63,64,65,66,67],"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)","Inclusion Criteria:\n\n* Undergoing gynecologic surgery with Stanford Healthcare\n* Intact uterus and cervix\n* At least one intact fallopian tube and ovary (on the same side)\n* Aged 18 years or older\n* Ability to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Known endometrial or cervical cancer or endometrial or cervical intraepithelial neoplasia\n* Status post bilateral salpingectomy or tubal ligation\n* Lack of consenting capacity\n* Positive preoperative pregnancy test\n* Active uterine bleeding (i.e. menses, etc.)\n* Intrauterine device in place\n* Non-English speaking (requires interpretor)",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":13,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":87},"Palo Alto","California","94304","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Rozelle Laquindanum","CONTACT","650-724-9948","rlaquind@stanford.edu",{"name":85,"role":86},"James Ford, MD","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},37.44188,-122.14302,[91],{"name":80,"role":81,"phone":92,"email":83},"(650) 724-9948",[94],{"name":85,"affiliation":13,"role":86},[],[],{"nct_id":4,"conditions":98,"biomarkers":102},[99,100,101],"Disorder of female genital organs","Malignant Female Reproductive System Neoplasm","Malignant Uterine Neoplasm",[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an interventional study designed to test the feasibility of a new collection method. It will enroll 50 participants consecutively, and all will receive the uterine lavage procedure.","completed","Molecular and Cellular Profiling of Uterine Lavage During Gynecologic Surgery","This study is looking at a new way to collect cells and fluid from the uterus during gynecologic surgery. It uses a procedure called uterine lavage, where saline (saltwater) is gently introduced into your uterus and then collected. Researchers want to see if this method is practical and safe, and to understand what kinds of cells are present in these samples. You might be able to join if you are 18 or older, having gynecologic surgery at Stanford Healthcare, and have an intact uterus, cervix, and at least one intact fallopian tube and ovary. The study aims to enroll 50 participants, and its current status is unclear.","The primary endpoint, characterizing cellular composition, is measured at the time of gynecologic surgery. No further follow-up is specified.",107,"If you participate, you will undergo the uterine lavage procedure during your gynecologic surgery. The study's primary goal is to characterize the cellular composition of the fluid collected at that time.","Not stated in the trial record.",[33],"v2"]