Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-01 @ 6:31 AM
Study NCT ID:
NCT07044505
Status:
RECRUITING
Last Update Posted:
2025-11-05
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of cellular composition in uterine lavage fluid', 'timeFrame': 'At time of gynecologic surgery', 'description': 'Quantification and classification of cell types obtained from uterine lavage specimens using cytology and/or flow cytometry.'}], 'secondaryOutcomes': [{'measure': 'Molecular profiling of uterine lavage specimens', 'timeFrame': 'At time of surgery', 'description': 'Analysis of RNA, DNA, or protein expression profiles in collected lavage fluid.'}, {'measure': 'Detection of inflammatory biomarkers in uterine lavage', 'timeFrame': 'At time of surgery', 'description': 'Measurement of cytokines or other markers associated with uterine immune status or pathology.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Cancer', 'Gynecologic Disease', 'Gynecological Surgery', 'Uterine Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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)'}, 'identificationModule': {'nctId': 'NCT07044505', 'briefTitle': 'Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Exploring the Molecular and Cellular Composition of Uterine Lavage Specimens Collected at the Time of Gynecologic Surgery.', 'orgStudyIdInfo': {'id': 'IRB-77882'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Group', 'description': 'Participants undergoing gynecologic surgery who agree to uterine lavage collection intraoperatively for molecular and cellular analysis.', 'interventionNames': ['Procedure: Uterine Lavage']}], 'interventions': [{'name': 'Uterine Lavage', 'type': 'PROCEDURE', 'description': 'Saline is introduced into the uterine cavity and retrieved during surgery to collect cells and fluid for downstream molecular and cellular analyses.', 'armGroupLabels': ['Single Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rozelle Laquindanum', 'role': 'CONTACT', 'email': 'rlaquind@stanford.edu', 'phone': '650-724-9948'}, {'name': 'James Ford, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Rozelle Laquindanum', 'role': 'CONTACT', 'email': 'rlaquind@stanford.edu', 'phone': '(650) 724-9948'}], 'overallOfficials': [{'name': 'James Ford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}