Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-25 @ 3:33 PM
Study NCT ID:
NCT00900250
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collecting and Storing Biological Samples From Young Patients With Hodgkin?s Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue, serum, plasma, nucleic acids, and peripheral blood mononuclear cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biologic specimen repository and database', 'timeFrame': 'Baseline to up to 5 years'}]}, 'conditionsModule': {'conditions': ['Ann Arbor Stage I Childhood Hodgkin Lymphoma', 'Ann Arbor Stage II Childhood Hodgkin Lymphoma', 'Ann Arbor Stage III Childhood Hodgkin Lymphoma', 'Ann Arbor Stage IV Childhood Hodgkin Lymphoma', 'Refractory Childhood Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "This laboratory study is collecting and storing samples of tissue and blood from young patients with Hodgkin's lymphoma. Collecting and storing samples of tumor tissue and blood from patients with cancer to study in the laboratory may help the study of cancer in the future.", 'detailedDescription': "OBJECTIVES:\n\nI. Establish a biologic specimen repository (of tumor tissue, tissue arrays, lymphoblastoid cell lines, host DNA, tumor and host RNA, serum, and plasma) and database linked to clinical features and outcomes from well-characterized cohorts of children and young adults with Hodgkin's lymphoma.\n\nII. Provide specimens from diagnosis, early response evaluation, completion of chemotherapy and radiotherapy, long-term follow up, and relapse to study prognostic factors for early response, relapse, long-term outcomes, and identification of new biological targets for therapy.\n\nOUTLINE: This is a multicenter study.\n\nPatients enrolled on Hodgkin's lymphoma (HL) therapeutic clinical trials undergo collection of tumor tissue samples at baseline and at relapse or disease progression. Serum and anticoagulated peripheral blood samples are collected at baseline, at week 1, on day 1 of course 2, after completion of chemotherapy, after completion of radiotherapy, at 1 year after diagnosis, and at relapse or disease progression.\n\nPatients with relapsed or progressive disease who plan to enroll on HL relapse/retrieval clinical trials undergo collection of tumor tissue, serum, and anticoagulated peripheral blood samples at relapse or disease progression.\n\nPatients enrolled more than 1 year after completion of treatment undergo collection of tumor specimens, serum, and anticoagulated peripheral blood samples at time of clinical evaluation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients newly diagnosed with HL or patients with HL enrolled (past or present) on COG or legacy HL clinical trials', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed Hodgkin's lymphoma (HL) meeting 1 of the following criteria:\n\n * Newly diagnosed, untreated HL (for patients under 22 years of age)\n * Past or present diagnosis of HL and past or present enrollment on a Children's Oncology Group (COG) or legacy HL clinical trial (for patients of any age)"}, 'identificationModule': {'nctId': 'NCT00900250', 'briefTitle': 'Collecting and Storing Biological Samples From Young Patients With Hodgkin?s Lymphoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Hodgkin Disease (HD) Banking Study', 'orgStudyIdInfo': {'id': 'AHOD04B1'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00378', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000495369'}, {'id': 'COG-AHOD04B1'}, {'id': 'AHOD04B1', 'type': 'OTHER', 'domain': 'Childrens Oncology Group'}, {'id': 'AHOD04B1', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-correlative (specimen collection and baking)', 'description': 'Patients enrolled on HL therapeutic clinical trials undergo collection of tumor tissue samples at baseline and at relapse or disease progression. Serum and anticoagulated peripheral blood samples are collected at baseline, at week 1, on day 1 of course 2, after completion of chemotherapy, after completion of radiotherapy, at 1 year after diagnosis, and at relapse or disease progression.\n\nPatients with relapsed or progressive disease who plan to enroll on HL relapse/retrieval clinical trials undergo collection of tumor tissue, serum, and anticoagulated peripheral blood samples at relapse or disease progression.\n\nPatients enrolled more than 1 year after completion of treatment undergo collection of tumor specimens, serum, and anticoagulated peripheral blood samples at time of clinical evaluation.', 'interventionNames': ['Other: Cytology Specimen Collection Procedure']}], 'interventions': [{'name': 'Cytology Specimen Collection Procedure', 'type': 'OTHER', 'otherNames': ['Cytologic Sampling'], 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-correlative (specimen collection and baking)']}]}, 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'90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Downey Medical Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's and Women's Hospital Long Beach", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Mattel Children's Hospital UCLA", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 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