Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT01728402
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-30
First Post:
2012-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pathogenesis of Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2012-11-13', 'studyFirstSubmitQcDate': '2012-11-13', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify and determine the frequency of mutations causing aberrant signaling pathway function in patients with acute leukemias (AL), lymphoproliferative disorders (LPD), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN)', 'timeFrame': 'After laboratory analyses are complete. Lab samples are collected at the time of a scheduled blood draw, bone marrow procedure, tissue biopsy, or other visit for usual medical care', 'description': 'Integrated functional genomics studies (whole genome sequencing, RNAi, proteomics, drug sensitivity, expression profiling) will be used to identify aberrant signaling pathways that contribute to the formation of hematologic malignancies.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Leukemia', 'Lymphoproliferative Disorders', 'Myeloproliferative Disorders', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'The cause of blood and bone marrow cancers is poorly understood; however, most research focuses on how cancer cells grow and develop. Because the causes of these cancers are unknown, current treatments may be unnecessarily harsh and often do not provide a cure. Identifying the causes of blood cancers would allow for the development of treatments that are more likely to provide a cure. To find the causes of blood and bone marrow cancers, we will look for specific cancer cell abnormalities that are responsible for cancer cell growth. We will then look to see if drugs that can reverse these abnormalities can kill cancer cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients of any age with a diagnosis or suspected diagnosis of a blood or bone marrow cancer may be a part of this study. The provider who will perform the blood draw, bone marrow aspirate, or biopsy as part of the patient's routine care will identify possible participants from their clinic schedule or patient list, give them information about what would be involved in participating in the study including possible risks, and ask if they are interested in participating.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected or confirmed diagnosis of AL, LPD, MDS, or MPD\n* Male or female of all ages\n* Willing and able to sign informed consent\n* Willing guardian consent for participants under 18 years of age\n\nExclusion Criteria:\n\n* No suspected or confirmed diagnosis of acute leukemias (AL), lymphoproliferative disorders (LPD), myelodysplastic syndromes (MDS), or myeloproliferative diseases (MPD)'}, 'identificationModule': {'nctId': 'NCT01728402', 'briefTitle': 'Pathogenesis of Hematologic Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Pathogenesis of Acute Leukemia, Lymphoproliferative Disorders, and Myeloproliferative Disorders', 'orgStudyIdInfo': {'id': 'IRB00004422'}, 'secondaryIdInfos': [{'id': '5R21CA159265', 'link': 'https://reporter.nih.gov/quickSearch/5R21CA159265', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood Draw', 'interventionNames': ['Procedure: blood draw, bone marrow procedure, or tissue biopsy']}], 'interventions': [{'name': 'blood draw, bone marrow procedure, or tissue biopsy', 'type': 'PROCEDURE', 'armGroupLabels': ['Blood Draw']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Marc Loriaux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marc Loriaux', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}