Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 7:23 AM
Study NCT ID:
NCT04021459
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'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'}, {'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'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'women with endometrial cancer'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative assessment', 'timeFrame': 'During surgery (at the ligature of the ovarian ligament)', 'description': 'Presence or not of at least one CTC during endometrial cancer surgery detected on two venipuncture site (peripheral and ovarian vein).'}], 'secondaryOutcomes': [{'measure': 'Quantitative assessment', 'timeFrame': 'Before surgery and during surgery', 'description': 'Number of CTC detected from each sampling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometrial cancer', 'circulating tumor cells', 'laparoscopy'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '36979364', 'type': 'RESULT', 'citation': 'Francini S, Duraes M, Rathat G, Macioce V, Mollevi C, Pages L, Ferrer C, Cayrefourcq L, Alix-Panabieres C. Circulating Tumor Cell Detection by Liquid Biopsy during Early-Stage Endometrial Cancer Surgery: A Pilot Study. Biomolecules. 2023 Feb 24;13(3):428. doi: 10.3390/biom13030428.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Early stage tumor is accessible for curative surgical treatment by laparoscopy but this kind of surgery may induce CTCs spread, and could be an explanation of this recurrence. Through this study, concordance between two blood punction sites, peripheral vein and ovarian vein, will be evaluated to detect these cells during surgery.', 'detailedDescription': 'The goal of this single-center clinical trial is to determine the best blood punction site to observe the spreading of CTC during surgery in endometrial cancer. CTCs are very rare events on blood and their detection require extremely sensitive technologies. This pilot study will investigate CTC spread during surgery on 10 patients with endometrial cancer.\n\nThe main objective is to compare venipuncture site for detection of CTCs in endometrial cancer during surgery. Blood samples are collected on a simple sampling (arm) compared to sampling as close as possible to the tumor (ovarian vein).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with endometrial cancer\n* Being affiliated or benefiting from a French social security system\n\nExclusion Criteria:\n\n* Patients with an other cancer'}, 'identificationModule': {'nctId': 'NCT04021459', 'acronym': 'E-CTC', 'briefTitle': 'Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery', 'orgStudyIdInfo': {'id': 'RECHMPL19_0178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'women with endometrial cancer', 'interventionNames': ['Procedure: blood samples']}], 'interventions': [{'name': 'blood samples', 'type': 'PROCEDURE', 'description': '3 samples: One before surgery on the arm vein (peripheral)\n\nTwo during the surgery, on two different venipuncture site :\n\n* One on the arm vein (peripheral)\n* One on ovarian vein (close to the tumor) All samples will be tested by the CellSearch method.', 'armGroupLabels': ['women with endometrial cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Gauthier RATHAT, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}