Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT02555267
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2015-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Geriatric Assessments in Elderly 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'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Average received relative dose intensity', 'timeFrame': '6 months', 'description': 'The dose intensity of each agent of R-CHOP chemotherapy was calculated by dividing the total received dose of the agent by the number of weeks of treatment. The relative dose intensity of each agents then was calculated by dividing the received dose intensity by the projected dose intensity for the agent. The sum of the relative dose intensities of the individual agents was divided by the number of agents in the R-CHOP to yield the average received relative dose intensity. In this study the average received relative dose intensity is calculated.'}], 'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': '2 years', 'description': 'Event-free survival was defined as death, relapse from complete remission, progression during or after treatment, and discontinuation or changes of therapy during treatments'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years'}, {'measure': 'Progression-free survival', 'timeFrame': '5 years'}, {'measure': 'Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['geriatric assessment', 'diffuse large B-cell lymphoma', 'activity of daily living', 'instrumental activity of daily living', "Charlson's comorbidity index"], 'conditions': ['Lymphoma, Large B-cell, Diffuse']}, 'descriptionModule': {'briefSummary': "This study investigate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients (≥ 65 years) with DLBCL treated with R-CHOP', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed CD20+ DLBCL\n* 65 years old or over\n* Scheduled to receive R-CHOP chemotherapy\n* Informed consent\n\nExclusion Criteria:\n\n* Other histology than CD20+ DLBCL\n* Primary central nervous system DLBCL\n* Patients with a diagnosis of cancer (other than basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, well differentiated thyroid cancer \\[papillary or follicular thyroid cancer\\]) within 3 years before the study entry or with any treatment for cancer within 3 years before entry\n* Consent withdrawal'}, 'identificationModule': {'nctId': 'NCT02555267', 'briefTitle': 'Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Multi-center, Prospective Cohort Study to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP', 'orgStudyIdInfo': {'id': 'GERIAD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly patients with DLBCL', 'description': 'Elderly patients (age\\>=65 years) with DLBCL treated with R-CHOP chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '561-712', 'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'overallOfficials': [{'name': 'Ho-Young Yhim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Catholic University of Korea', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, {'name': 'Kosin University Gospel Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ho-Young Yhim', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}