Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-05 @ 5:54 PM
Study NCT ID:
NCT04586959
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A prospective multi-center non-inferiority randomized study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 278}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive peritoneal cytology (PC)', 'timeFrame': 'Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group', 'description': 'Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.'}], 'secondaryOutcomes': [{'measure': 'Post-operative positive PC', 'timeFrame': 'Immediately after closure of the vaginal cuff', 'description': 'Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.'}, {'measure': 'Lymphovascular space invasion (LVSI)', 'timeFrame': 'During surgery', 'description': 'LVSI is defined as the presence of tumor cells within a definite endothelial-lined space (lymphatics or blood vessels) at the advancing edge of the tumor as it invades the myometrium, within an endometrial polyp, or within the endometrial stroma.'}, {'measure': 'Percentage of myometrial invasion (MI)', 'timeFrame': 'During surgery', 'description': 'Defined as the % of invasion into the myometrium from the endomyometrial junction'}, {'measure': 'Extent of lymph node metastases', 'timeFrame': 'During surgery', 'description': 'Defined as presence of isolated tumor cells (ITC - \\<0.2 mm), or micrometastasis (mm - 0.2 - 2 mm), or macrometastasis (MM - \\> 2 mm), whichever is greater.'}, {'measure': 'Operative time', 'timeFrame': '1 day', 'description': 'Defined as time from start of operation to closure of skin in minutes as documented in the electronic medical record'}, {'measure': 'Surgical morbidity', 'timeFrame': 'Intra-operative and up to 30 days post-surgery', 'description': 'Surgical morbidity (CTCAE v5.0) grade 3 and higher, or any grade of the following adverse events: colonic fistula, colonic perforation, enterovesical fistula, gastrointestinal fistula, ileus, intra-abdominal hemorrhage, rectal fistula, rectal perforation, small intestinal perforation, abdominal infection, pelvic infection, vaginal infection, intra-operative arterial injury, venous injury, intra-operative gastrointestinal injury, intra-operative hemorrhage, intra-operative neurological injury, intra-operative urinary injury, and post-operative hemorrhage.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['endometrial', 'cancer', 'uterine', 'manipulator'], 'conditions': ['ENDOMETRIAL CANCER']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.', 'detailedDescription': 'In most cases, patients who have early stage endometrial cancer undergo a surgery to remove the uterus, cervix, tubes, ovaries, and occasionally lymph nodes. This is usually done through a minimally invasive (not a large incision) surgery. To accomplish this, the uterus needs to be manipulated (moved around) to help the surgeon complete your surgery. This is usually done with a device called a uterine manipulator and the majority of surgeons use this device in any patient undergoing a minimally invasive hysterectomy (removal of the uterus and cervix).\n\nEven though the majority of surgeons use a manipulator, there are some surgeons who believe there is a possibility that cancer cells inside the uterus can be spilled into the abdomen through the fallopian tubes. This may cause a higher risk of spreading the cancer and or of the cancer coming back.\n\nCurrently, there are very limited research studies directly looking at whether the uterine manipulator may cause these cells to appear in the abdomen.\n\nThe purpose of this study is to see if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.\n\nA computer program will randomly assign the subjects to one of two groups. One group will have minimally invasive surgery with the use of a uterine manipulator and the other group will have minimally invasive surgery without the use of a uterine manipulator.\n\nResearchers will use the information from this study to decide how best to take care of patients undergoing minimally invasive surgery for uterine cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA subject will be considered eligible for inclusion in this study if all the following criteria are met:\n\n1. Patient must be greater than or equal to 18 years old.\n2. Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)\n3. Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.\n4. CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1).\n\n6\\. Signed informed consent and ability to comply with follow-up. 7. Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure.\n\nExclusion Criteria:\n\nA subject must not have any of the following criteria:\n\n1. Planned laparotomic hysterectomy\n2. On progesterone therapy to treat their endometrial cancer\n3. Any prior pelvic irradiation'}, 'identificationModule': {'nctId': 'NCT04586959', 'acronym': 'MAN-U', 'briefTitle': 'Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer', 'orgStudyIdInfo': {'id': 'H-46373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgery With UM (Arm MAN UA)', 'description': 'Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)', 'interventionNames': ['Device: Surgery with UM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery Without UM (Arm Control)', 'description': 'Subjects that undergo a MIS approach without a uterine manipulator (control arm)', 'interventionNames': ['Device: Surgery without UM']}], 'interventions': [{'name': 'Surgery with UM', 'type': 'DEVICE', 'description': 'The experimental group will have MIS with the placement of a uterine manipulator', 'armGroupLabels': ['Surgery With UM (Arm MAN UA)']}, {'name': 'Surgery without UM', 'type': 'DEVICE', 'description': 'The control group will have MIS without the placement of a uterine manipulator', 'armGroupLabels': ['Surgery Without UM (Arm Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'SUSPENDED', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Costales, MD', 'role': 'CONTACT', 'email': 'costales@bcm.edu', 'phone': '713-798-3495'}], 'facility': 'Baylor College of Medicine- McNair Campus', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Costales, MD', 'role': 'CONTACT', 'email': 'costales@bcm.edu', 'phone': '713-798-3495'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Costales, MD', 'role': 'CONTACT', 'email': 'costales@bcm.edu', 'phone': '713-798-3495'}], 'facility': 'Ben Taub General Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Costales, MD', 'role': 'CONTACT', 'email': 'costales@bcm.edu', 'phone': '713-798-3495'}], 'facility': 'Harris Health System - Smith Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Anthony Costales, MD', 'role': 'CONTACT', 'email': 'costales@bcm.edu', 'phone': '713-798-3495'}, {'name': 'Roberto Vargas, MD', 'role': 'CONTACT', 'email': 'vargasr@ccf.org', 'phone': '216-444-3414'}], 'overallOfficials': [{'name': 'Anthony Costales, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anthony Costales, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Obstetrics & Gynecology', 'investigatorFullName': 'Anthony Costales, MD', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}