Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT01789060
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
p-AKT Expression on Clinical Outcomes in Malignant 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'paraffin-embedded biopsy specimen or unstained slides for immunostaining of p-AKT'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-07', 'studyFirstSubmitDate': '2013-02-07', 'studyFirstSubmitQcDate': '2013-02-07', 'lastUpdatePostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subgroup analysis of overall survival according to International Prognostic Index risk groups', 'timeFrame': 'study entry'}], 'primaryOutcomes': [{'measure': 'Difference of overall survival according to p-AKT status in malignant lymphoma', 'timeFrame': 'study entry'}], 'secondaryOutcomes': [{'measure': 'Subgroup analysis of overall survival according to histologic subtypes (GCB vs non GCB)', 'timeFrame': 'study entry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Lymphoma', 'P13K-AKT Pathway Deregulation']}, 'referencesModule': {'references': [{'pmid': '24356628', 'type': 'DERIVED', 'citation': 'Hong JY, Hong ME, Choi MK, Kim YS, Chang W, Maeng CH, Park S, Lee SJ, Do IG, Jo JS, Jung SH, Kim SJ, Ko YH, Kim WS. The impact of activated p-AKT expression on clinical outcomes in diffuse large B-cell lymphoma: a clinicopathological study of 262 cases. Ann Oncol. 2014 Jan;25(1):182-8. doi: 10.1093/annonc/mdt530.'}]}, 'descriptionModule': {'briefSummary': 'PI3K(phosphatidylinositol 3-kinase)/AKT pathway is an important oncogenic signaling pathway. However, clinical information about the significance of p-AKT expression in malignant lymphoma is not fully understood yet. In this study, we investigated the overexpression of p-AKT and its prognostic implication in malignant lymphoma.', 'detailedDescription': 'Recently, among diverse oncogenic signaling pathways, a number of studies have focused on the significance of oncogenic PI3K/AKT (phophatidylinositol 3-kinase/serine-threonine kinase, also known as protein kinase B \\[PKB\\]) pathway. PI3K(phosphatidylinositol 3-kinase)/AKT pathway phosphorylates and activates AKT as phosphorylated AKT (p-AKT) and plays a critical role promoting malignant phenotype and has prognostic significance in various solid cancers.\n\nHowever, a systematic approach on the impact of p-AKT overexpression on clinical outcomes has not been performed in malignant lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with malignant lymphoma who are treated in a tertiary hospital in Korea (Samsung Medical Center)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. the patients were pathologically confirmed of malignant lymphoma, according to the World Health Organization classification;\n2. the patients had adequate paraffin-embedded biopsy specimen or unstained slides for immunostaining of p-AKT.\n\nExclusion Criteria:\n\n1\\. Primary central nervous system lymphoma was excluded in this study'}, 'identificationModule': {'nctId': 'NCT01789060', 'briefTitle': 'p-AKT Expression on Clinical Outcomes in Malignant Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Impact of Activated p-AKT Expression on Clinical Outcomes in Malignant Lymphoma : A Clinicopathological Study', 'orgStudyIdInfo': {'id': '2013-01-047'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'p-AKT', 'description': 'p-AKT immunohistochemical staining,high p-AKT expression (upper quartile), low p-AKT expression (lower 3 quartiles)', 'interventionNames': ['Other: p-AKT immunohistochemical staining']}], 'interventions': [{'name': 'p-AKT immunohistochemical staining', 'type': 'OTHER', 'description': 'p-AKT staining on the adequate paraffin-embedded biopsy specimen or unstained slides', 'armGroupLabels': ['p-AKT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Seog Kim, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Seog Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}