Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT01715961
Status:
COMPLETED
Last Update Posted:
2016-10-05
First Post:
2012-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-04', 'studyFirstSubmitDate': '2012-04-11', 'studyFirstSubmitQcDate': '2012-10-25', 'lastUpdatePostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'at 18 months'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'at 24 months'}, {'measure': 'rate of over grade 2 toxicities', 'timeFrame': 'at the first and second courses of chemotherapy (day 21 and day 42)'}, {'measure': 'determination of both molecular subtypes GCB and ABC', 'timeFrame': 'at 24 months', 'description': 'according DASL technology (c-DNA mediated annealing selection extension and ligation)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['70 years old', 'DLBCL', 'Rituximab-CHOP', 'Sarcopenia'], 'conditions': ['Diffuse Large B Cell Lymphoma', 'Grade IIIB Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': 'This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.', 'detailedDescription': 'Sarcopenia status is assessed by CT scan imaging on the overall survival at 18 months in patients older than 70 years with diffuse large B-cell lymphoma treated by R-CHOP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>= 70 years\n* DLBCL, grade IIIB follicular lymphoma or histologically proven transformed low grade lymphoma\n* Whatever the IPI score and the performance status\n* Treated by Rituximab-CHOP or Rituximab-mini-CHOP\n* CT scan imaging performed one month or less before inclusion\n* Signed informed consent\n\nExclusion Criteria:\n\n* No initial CT scan imaging performed more than one month before inclusion\n* Positivity for HCV, HBV and HIV\n* Anthracycline contra-indication'}, 'identificationModule': {'nctId': 'NCT01715961', 'acronym': 'SARCOPENIE', 'briefTitle': 'Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Henri Becquerel'}, 'officialTitle': 'Multicentric Prospective Study to Assess the Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'CHB 11-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'anthropometric measurement', 'description': 'The muscle area assessed by CT scan imaging at a lumbar vertebral landmark (L3) at the time of diagnosis, at the end of treatment, at 12 and 18 months\n\n* anthropometric measures (weight, height, BMI, brachial and calf circumference) and MNA (mini nutritional assessment)\n* albuminemia, transthyretin, orosomucoid, CRP\n* functional test to attest the muscular strength: hand grip test, unipodal test, up and go test\n* hematological and non-hematological chemotherapy toxicities of cycle 1 and cycle 2\n* OS and PFS at 18 and 24 months\n* GCB and ABC phenotypes determined by immunohistochemistry and transcriptome analysis', 'interventionNames': ['Procedure: anthropometric measurement']}], 'interventions': [{'name': 'anthropometric measurement', 'type': 'PROCEDURE', 'otherNames': ['Hand Grip strength test', 'Timed get up and go test'], 'description': 'To attest the muscular strength: hand grip test, balance test, up and go test', 'armGroupLabels': ['anthropometric measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Fabrice JARDIN, MD;PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Henri Becquerel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Henri Becquerel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}