Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-18 @ 6:57 PM
Study NCT ID:
NCT02691351
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2016-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-02-21', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Overall response rate to primary treatment and salvage treatment', 'timeFrame': '5 years'}, {'measure': 'Progression-free survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-Hodgkin T-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about conical features and treatment outcomes of each subtype should be accumulated to establish treatment strategy. However, the majority of previous data for non-Hodgkin T-cell lymphoma was from small case series of single institute. Furthermore, as novel drugs were developed for the treatment of relapsed or refractory T-cell lymphoma, the date from patients who were treated with those novel drugs are especially required because their outcomes may reflect the outcomes of currently available treatments. Thus, a multinational, multicenter prospective registry study is needed to provide information useful for establishing treatment strategies for T-cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'T-cell non-Hodgkin lymphoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically diagnosed Mature T-cell non-Hodgkin lymphoma based on the World Health Organization classification 2008\n* Newly diagnosed patients without a previous treatment history for T-cell lymphoma or relapsed/refractory T-cell lymphoma patients\n* Age ≥19 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Hodgkin lymphoma\n* non-Hodgkin B-cell lymphoma\n* Immature non-Hodgkin T-cell lymphoma: Precursor T-lymphoblastic lymphoma/leukemia\n* Not understanding informed consent'}, 'identificationModule': {'nctId': 'NCT02691351', 'briefTitle': 'Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study', 'orgStudyIdInfo': {'id': '2015-11-070'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-Hodgkin T-cell Lymphoma', 'interventionNames': ['Other: Prospective Registry']}], 'interventions': [{'name': 'Prospective Registry', 'type': 'OTHER', 'description': 'Survival and disease status follow-up at 1st primary treatment, 1st salvage treatment and 2nd salvage treatment\n\n1. Regimen\n2. Response Evaluation\n3. SUSAR(Suspected, Unexpected, Serious, Adverse Reaction) collection', 'armGroupLabels': ['non-Hodgkin T-cell Lymphoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won seog Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Won Seog Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}