Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT00159003
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Genetic Factors Related to Predisposition and Prognosis of Hematological Malignancies in Israel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System 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': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA only'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drug metabolism and disposition enzymes'], 'conditions': ['Acute Myeloid Leukemia', 'Chronic Lymphocytic Leukemia', 'Chronic Myelogenous Leukemia']}, 'referencesModule': {'references': [{'pmid': '14582082', 'type': 'BACKGROUND', 'citation': 'Chanock S. Genetic variation and hematology: single-nucleotide polymorphisms, haplotypes, and complex disease. Semin Hematol. 2003 Oct;40(4):321-8. doi: 10.1016/s0037-1963(03)00198-7.'}]}, 'descriptionModule': {'briefSummary': 'There are naturally occuring variations in the genetic makeup of all of us. Some of these variations may contribute to a change in susceptibility toward different diseases or change the prognosis.\n\nWe are studying these genetic variations in patients with leukemia. The genes we are studying are those which influence detoxification of drugs and toxins.', 'detailedDescription': 'We have prepared DNA on patients with leukemia (AML, CML and CLL) and we are studying the influence of polymorphisms in drug metabolism and disposition genes on predisposition and prognosis of these types of leukemia. The genes we are studying include: MDR1, CYP3A4, NQO1, NAT1/2, GST, hOCT. We plan to study other genes that may be contributory.\n\nStudy includes comparing the frequency of polymorphisms in these genes with the frequency in the general population and the study of DNA biding proteins which bind at the sites of these polymorphisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Hadassah Hospital with AML or CLL.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of acute myeloid leukemia or chronic lymphocytic leukemia\n\nExclusion Criteria:\n\n* under 18 years of age'}, 'identificationModule': {'nctId': 'NCT00159003', 'briefTitle': 'Analysis of Genetic Factors Related to Predisposition and Prognosis of Hematological Malignancies in Israel', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Molecular Analysis of Genetic Elements Which May Influence Predisposition and Prognosis of Hematological Malignancies in Different Ethnic Groups in Israel', 'orgStudyIdInfo': {'id': '132910-HMO-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': 'IL91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Deborah G Rund, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deborah Rund', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Hematologist', 'investigatorFullName': 'Deborah Rund', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}