Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-10 @ 2:42 PM
Study NCT ID:
NCT03211702
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2017-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma Patients-2 (GERIAD2)
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2017-07-06', 'studyFirstSubmitQcDate': '2017-07-06', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Average received ralative 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, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['geriatric assessments', '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 will validate 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 DLBCL patients (≥ 65 years) treated with R-CHOP', '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': 'NCT03211702', 'briefTitle': 'Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma Patients-2 (GERIAD2)', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Multi-center, Prospective Cohort Study-II to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP (GERIAD2)', 'orgStudyIdInfo': {'id': 'GERIAD2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly DLBCL patients', 'description': 'Elderly DLBCL patients (age\\>=65 years) treated with R-CHOP chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hwasun', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'zip': '561-712', 'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, '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'}, {'name': 'Chungnam National University Hospital', 'class': 'OTHER'}, {'name': 'Yeungnam University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ho-Young Yhim', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}