Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01043302
Status:
COMPLETED
Last Update Posted:
2010-07-28
First Post:
2010-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Cross Sectional Study of Primary Intestine Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 545}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-27', 'studyFirstSubmitDate': '2010-01-04', 'studyFirstSubmitQcDate': '2010-01-05', 'lastUpdatePostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Study entry'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Study entry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lymphoma, intestine, outcome, quality of life'], 'conditions': ['Non-Hodgkin Lymphoma of Intestine']}, 'referencesModule': {'references': [{'pmid': '21148334', 'type': 'DERIVED', 'citation': 'Kim SJ, Kang HJ, Kim JS, Oh SY, Choi CW, Lee SI, Won JH, Kim MK, Kwon JH, Mun YC, Kwak JY, Kwon JM, Hwang IG, Kim HJ, Park J, Oh S, Huh J, Ko YH, Suh C, Kim WS. Comparison of treatment strategies for patients with intestinal diffuse large B-cell lymphoma: surgical resection followed by chemotherapy versus chemotherapy alone. Blood. 2011 Feb 10;117(6):1958-65. doi: 10.1182/blood-2010-06-288480. Epub 2010 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether whether surgical resection followed by chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and quality of life (QOL) in patients with primary intestinal lymphoma.', 'detailedDescription': "Intestine is the one of commonly involved extranodal sites of non-Hodgkin's lymphoma (NHL). Thus, small and large Intestine account for approximately 30-40% of primary gastrointestinal tract lymphoma. More than 70% of intestinal lymphoma presents as localized disease, and surgery such as bowel resection is performed in many patients with intestinal lymphoma for diagnosis and treatment. However, it is still unclear whether surgical resection followed by chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and quality of life (QOL). Thus, we analyze the clinical features and treatment outcome of patients with NHL of intestine, and at the same time perform a multicenter cross-sectional study about the QOL in survivors of intestine NHL. We evaluates the treatment outcomes of patients with intestine NHL from hospitals affiliated with the Consortium for Improving Survival of Lymphoma (CISL) in Korea. We assess the QOL of survivors who completed their treatment using the EORTC QLQ-C30 questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'University hosptial, general hospital, Cancer institute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary intestine lymphoma.\n\nDefinition of primary intestine lymphoma:\n\n1. Dominant site should be small and large intestine with or without regional lymph node involvement\n2. Distant lymph node involvement can be allowed if the intestine lesion is the presenting site\n3. Contiguous involvement of other organs such as liver, spleen can be allowed\n\nExclusion Criteria:\n\n* Intestine involvement as a dissemination process in stage IV nodal lymphoma'}, 'identificationModule': {'nctId': 'NCT01043302', 'briefTitle': 'Multicenter Cross Sectional Study of Primary Intestine Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Multicenter Cross Sectional Study of Primary Intestine Lymphoma: Treatment Outcome and Quality of Life', 'orgStudyIdInfo': {'id': '2008-09-060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery+chemotherapy', 'description': 'Primary mass was resected and systemic chemotherapy was performed as an adjuvant treatment'}, {'label': 'Chemotherapy', 'description': 'Only treated with chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seok Jin Kim, MD.,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kim, Seok Jin', 'oldOrganization': 'Samsung Medical Center'}}}}