Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT00897767
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D054438', 'term': 'Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative'}, {'id': 'D001752', 'term': 'Blast Crisis'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D054429', 'term': 'Leukemia, Myelomonocytic, Juvenile'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D007943', 'term': 'Leukemia, Hairy Cell'}, {'id': 'D054066', 'term': 'Leukemia, Large Granular Lymphocytic'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}, {'id': 'D007946', 'term': 'Leukemia, Mast-Cell'}, {'id': 'D015463', 'term': 'Leukemia, Prolymphocytic'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D015458', 'term': 'Leukemia, T-Cell'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D034721', 'term': 'Mastocytosis, Systemic'}, {'id': 'D008415', 'term': 'Mastocytosis'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1873}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2014-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Providing a mechanism for sample collection and submission for diagnostic review to determine eligibility for enrollment on ECOG leukemia clinical trials', 'timeFrame': '6 month'}, {'measure': 'Obtaining baseline sample collection for correlative studies outlined in parent clinical trials', 'timeFrame': '6 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['accelerated phase chronic myelogenous leukemia', 'atypical chronic myeloid leukemia, BCR-ABL1 negative', 'blastic phase chronic myelogenous leukemia', 'childhood chronic myelogenous leukemia', 'chronic myelomonocytic leukemia', 'chronic phase chronic myelogenous leukemia', 'juvenile myelomonocytic leukemia', 'meningeal chronic myelogenous leukemia', 'progressive hairy cell leukemia, initial treatment', 'recurrent adult acute lymphoblastic leukemia', 'recurrent adult acute myeloid leukemia', 'recurrent adult T-cell leukemia/lymphoma', 'recurrent childhood acute lymphoblastic leukemia', 'recurrent childhood acute myeloid leukemia', 'refractory chronic lymphocytic leukemia', 'refractory hairy cell leukemia', 'relapsing chronic myelogenous leukemia', 'stage I adult T-cell leukemia/lymphoma', 'stage I chronic lymphocytic leukemia', 'stage II adult T-cell leukemia/lymphoma', 'stage II chronic lymphocytic leukemia', 'stage III adult T-cell leukemia/lymphoma', 'stage III chronic lymphocytic leukemia', 'stage IV adult T-cell leukemia/lymphoma', 'stage IV chronic lymphocytic leukemia', 'untreated adult acute lymphoblastic leukemia', 'untreated adult acute myeloid leukemia', 'untreated childhood acute lymphoblastic leukemia', 'untreated childhood acute myeloid leukemia and other myeloid malignancies', 'T-cell large granular lymphocyte leukemia', 'adult acute myeloid leukemia in remission', 'adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(15;17)(q22;q12)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'secondary acute myeloid leukemia', 'childhood acute myeloid leukemia in remission', 'acute undifferentiated leukemia', 'mast cell leukemia', 'adult acute lymphoblastic leukemia in remission', 'childhood acute lymphoblastic leukemia in remission', 'prolymphocytic leukemia', 'untreated hairy cell leukemia'], 'conditions': ['Leukemia', 'Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about diagnosing cancer and determine a patient's eligibility for a treatment clinical trial. It may also help the study of cancer in the future.\n\nPURPOSE: This laboratory study is collecting tissue samples from patients with leukemia or other blood disorders who are planning to enroll in an ECOG leukemia treatment clinical trial.", 'detailedDescription': "OBJECTIVES:\n\n* To provide a mechanism for sample collection and submission for diagnostic review to determine eligibility of patients with suspected leukemia or related hematologic disorders for enrollment on ECOG leukemia clinical trials.\n* To obtain baseline samples for correlative studies outlined in parent clinical trials.\n\nOUTLINE: This is a cohort, multicenter study.\n\nPatients submit bone marrow and/or blood samples. The samples are studied to determine patients' eligibility for ECOG leukemia treatment clinical trials. Samples may be stored for future correlative studies related to ECOG treatment clinical trials."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potential candidates for ECOG-ACRIN Leukemia Trials', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Candidate for enrollment on an ECOG treatment clinical trial for acute or chronic leukemia\n\n * Suspected clinical diagnosis and protocol ID number of the treatment clinical trial under consideration must be submitted to ECOG's Leukemia Translational Studies Laboratory to ensure that the required antibody panels are used and functional assays are performed\n* Chosen ECOG treatment clinical trial must be active and accruing\n\n * Patient must not have begun treatment on the ECOG treatment clinical trial\n* Patient may be concurrently enrolled on this laboratory study and a treatment clinical trial if immediate treatment is medically necessary\n\n * If subsequent diagnostic review alters the original diagnosis, the patient will be removed from the treatment clinical trial\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics"}, 'identificationModule': {'nctId': 'NCT00897767', 'briefTitle': 'Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Ancillary Laboratory Protocol For the Collection of Diagnostic Material On Patients Considered For ECOG Treatment Trials For Leukemia Or Related Hematologic Disorders', 'orgStudyIdInfo': {'id': 'CDR0000357586'}, 'secondaryIdInfos': [{'id': 'ECOG-E3903'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'biologic sample preservation procedure', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85259-5499', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Presbyterian Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301-9019', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80933', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose Cancer Center at Penrose Hospital', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Anthony Central Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Presbyterian - 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