Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT02143869
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2014-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution of Corporeal Composition in the PeriOperative Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 374}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2014-05-18', 'studyFirstSubmitQcDate': '2014-05-18', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'nutritional intake during perioperative period', 'timeFrame': '1 month', 'description': 'One of the secondary objective is to investigate the relationship between change in body composition and perioperative nutritional intake.'}, {'measure': 'cancer type and stage', 'timeFrame': '6 months', 'description': 'One of the secondary objective is to investigate the relationship between baseline body composition and the type and stage of cancer.'}, {'measure': 'comparison of the body composition obtained by BIA and anthropometric measurements.', 'timeFrame': '6 months', 'description': 'One of the secondary objective is to compare the body composition obtained by Bioelectrical Impedance Analysis (BIA) and by anthropometric measurements.'}], 'primaryOutcomes': [{'measure': 'body composition', 'timeFrame': '1 month', 'description': 'The primary objective is to study the change in body composition (fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water) during the perioperative period with respect to short, mid and long term outcome.'}], 'secondaryOutcomes': [{'measure': 'perioperative complications', 'timeFrame': '6 months', 'description': 'One of the secondary objective is to investigate the relationship between baseline body composition and the occurrence of surgical complications.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastrointestinal cancer', 'Lung cancer', 'Bioelectrical Impedance analysis', 'Body composition', 'Perioperative'], 'conditions': ['Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal)', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Denutrition and Obesity are risk factors for perioperative surgical complications.\n\nIn patient with cancer, incidence of denutrition is markedly increased. Surgical resection of cancer induces a high intensity cellular stress response and catabolism reinforcing the risk for perioperative denutrition.\n\nIn this study, we thought to investigate the change in body composition during the perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis (BIA).', 'detailedDescription': 'Body composition measurements will be performed before surgical procedure (7 days) and at day 1, day 5, 1 month, 3 months and 6 months after surgery.\n\nOthers data will be recorded including anthropometric measurements, nutritional intake, occurence of surgical complication, type of surgical procedure, type and stage of cancer, and CT-scan measurements of subcutaneous abdominal fat, visceral fat and peri-renal fat before surgery and at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal) or lung cancer undergoing curative surgical resection as part of their disease management.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal)\n* Or Lung cancer\n* And planned surgical resection\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Surgical procedure planned \\< 48 h\n* Pregnancy\n* Presence of a cardiac stimulator'}, 'identificationModule': {'nctId': 'NCT02143869', 'acronym': 'ECCOP', 'briefTitle': 'Evolution of Corporeal Composition in the PeriOperative Period', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Européen Marseille'}, 'officialTitle': 'Perioperative Body Composition Changes in Patients Undergoing Gastrointestinal or Lung Cancer Surgery', 'orgStudyIdInfo': {'id': '2013-A01346-39'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bioelectrical Impedance Analysis', 'type': 'DEVICE', 'description': 'Measurements of body composition including fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Européen Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Jérôme ALLARDET-SERVENT, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Européen Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Européen Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'Jerome Allardet-Servent, MD', 'investigatorAffiliation': 'Hôpital Européen Marseille'}}}}