Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-04-10 @ 1:45 AM
Study NCT ID:
NCT01887769
Status:
UNKNOWN
Last Update Posted:
2017-01-06
First Post:
2013-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Composition Analysis for Patient With Lung Cancer Using Computed Tomography Image Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2013-02-13', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of muscle area (cm2/m2) at the level of the third lumbar vertebra', 'timeFrame': 'at the time of the diagnosis of lung cancer and one year following it.'}, {'measure': 'Change of fat area (cm2/m2) at the level of the third lumbar vertebra', 'timeFrame': 'at the time of the diagnosis of lung cancer and one year following it.'}], 'secondaryOutcomes': [{'measure': 'days of survival', 'timeFrame': 'From the time of the diagnosis of lung cancer until one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung cancer', 'Body composition analysis', 'Ct-Scan', 'Muscle mass', 'Cachexia'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, it has been mainly studied from several assessment methods which do not usually differentiate muscle from other tissues.\n\nAim: To analyze body composition of patients with lung cancer at diagnosis using computed tomography (CT-Scan) image analysis.\n\nMethods: This is a retrospective study extending over a period of 3 years conducted at the Institut universitaire de cardiologie et de pneumologie de Québec (2009-2012). We listed patients newly diagnosed with lung cancer who had a thoraco-abdominal CT-scan performed in our institution. Following the collection of clinical data from patient records, we used SliceOmatic software to quantify muscle area, visceral fat area and subcutaneous fat area from a single abdominal cross-sectional image at the level of the third lumbar vertebra.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Lung cancer patients, at diagnosis, following in oncology clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women\n* Between 40-80 years of age\n* Primary lung cancer diagnosed between 2009 and 2012\n* CT-Scan done at the time of the diagnosis\n\nExclusion Criteria:\n\n* Chemotherapy, radiotherapy or surgery at the time of the first Ct-Scan image\n* History of other cancer (during the last five years)'}, 'identificationModule': {'nctId': 'NCT01887769', 'acronym': 'BAT-SCAN', 'briefTitle': 'Body Composition Analysis for Patient With Lung Cancer Using Computed Tomography Image Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}, 'orgStudyIdInfo': {'id': '20824'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung cancer patient at diagnosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Didier Saey, PhD', 'role': 'CONTACT', 'email': 'didier.saey@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '2614'}, {'name': 'Didier Saey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut universitaire de cardiologie et de pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Didier Saey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Didier Saey', 'investigatorAffiliation': "Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec"}}}}