Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 5:23 AM
Study NCT ID:
NCT01366157
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2011-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Biomarker Levels in Tissue Samples From Young Patients With Low-risk Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-13', 'studyFirstSubmitDate': '2011-06-02', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variability of HGAL protein expression in pediatric patients with low-risk classical Hodgkin lymphoma (cHL)'}, {'measure': 'Variability of HGAL staining between low-risk and intermediate-risk pediatric patients with cHL'}, {'measure': 'Variability of HGAL staining as assessed by tissue array in pediatric patients with intermediate-risk cHL'}, {'measure': 'Correlation of rapid or slow early response in the intermediate-risk group with HGAL protein expression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['childhood favorable prognosis Hodgkin lymphoma', 'stage I childhood Hodgkin lymphoma', 'stage II childhood Hodgkin lymphoma', 'stage III childhood Hodgkin lymphoma', 'stage IV childhood Hodgkin lymphoma', 'childhood lymphocyte depletion Hodgkin lymphoma', 'childhood lymphocyte predominant Hodgkin lymphoma', 'childhood mixed cellularity Hodgkin lymphoma', 'childhood nodular lymphocyte predominant Hodgkin lymphoma', 'childhood nodular sclerosis Hodgkin lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.\n\nPURPOSE: This research trial is studying protein biomarker levels in tissue samples from young patients with low-risk Hodgkin lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\n* To investigate the variability of expression of human geminal-center-associated lymphoma (HGAL) protein in pediatric low-risk Hodgkin lymphoma.\n* To assess the variability of HGAL staining between risk groups by comparing samples from subjects enrolled in the low-risk study AHOD0431 with subject samples enrolled in AHOD0031 for intermediate-risk classical Hodgkin Lymphoma (cHL).\n* To assess the variability of HGAL staining by evaluating a tissue array created from subjects with intermediate-risk cHL.\n* To correlate rapid or slow early-response in the intermediate-risk group with HGAL protein expression.\n\nOUTLINE: Paraffin-embedded tissue samples and tissue microarrays are analyzed for protein expression by IHC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed with low-risk classical Hodgkin lymphoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosed with low-risk classical Hodgkin lymphoma (cHL)\n* Samples available from patients enrolled in the low-risk study COG-AHOD0431 and in the intermediate-risk cHL study COG-AHOD0031\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT01366157', 'briefTitle': 'Protein Biomarker Levels in Tissue Samples From Young Patients With Low-risk Hodgkin Lymphoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Investigation to Evaluate the Levels of Human Germinal-center-Associated Lymphoma (HGAL) Protein in Pediatric Hodgkin Lymphoma and Correlate With Early Response', 'orgStudyIdInfo': {'id': 'AHOD11B1'}, 'secondaryIdInfos': [{'id': 'COG-AHOD11B1', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CDR0000701020', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'NCI-2011-02859', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'microarray analysis', 'type': 'GENETIC'}, {'name': 'protein expression analysis', 'type': 'GENETIC'}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frank G. Keller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Emory Children's Center - Atlanta"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}