Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-02-11 @ 11:51 AM
Study NCT ID:
NCT02435550
Status:
TERMINATED
Last Update Posted:
2019-12-20
First Post:
2015-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCare for Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D025202', 'term': 'Molecular Diagnostic Techniques'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'whyStopped': 'Halted due to funding issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2015-04-20', 'studyFirstSubmitQcDate': '2015-04-30', 'lastUpdatePostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response', 'timeFrame': 'Up to 5 years', 'description': 'The overall response rate (ORR) is defined as achieving a complete remission (CR), partial remission (PR), and/or hematological improvement based on 2006 International Working Group (IWG) criteria (Cheson, et al. Blood 2006).'}], 'secondaryOutcomes': [{'measure': 'Number of patients with drug-related Grade 3 and Grade 4 adverse events', 'timeFrame': 'Up to 5 years', 'description': 'Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 4. Adverse event incidences will be compared to individual pharmacogenetic gene variants.'}, {'measure': 'Progression-free survival after treatment', 'timeFrame': 'Up to five years', 'description': 'The disease free survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.'}, {'measure': 'Overall survival after treatment', 'timeFrame': 'Up to 5 years', 'description': 'The overall survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndromes', 'Acute Myeloid Leukemia', 'Acute Myelogenous Leukemia', 'Acute Lymphoid Leukemia', 'Leukemia, Acute Lymphoblastic', 'Multiple Myeloma', 'Myelofibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use genomic information from individual patients to create simulation avatars that will be used to predict novel drug combinations with therapeutic potential.', 'detailedDescription': 'As part of normal clinical care, subjects will undergo peripheral blood draws and biopsies for disease assessment of their cancer. In cases of hematological malignancies, bone marrow aspiration \\& biopsy are routinely performed.\n\nAs part of this project, the following will be done to the samples collected and with clinical outcomes data:\n\n* donate peripheral blood specimens whenever blood is already being drawn for clinical purposes.\n* donate bone marrow aspiration samples whenever a bone marrow aspiration procedure is already being done for clinical purposes.\n* donate saliva whenever blood draw is already being done for clinical purposes.\n* allow the investigators to perform gene mutation profiling.\n* allow the investigators to study gene mutation results.\n* allow the investigators to perform pharmacogenetic profiling.\n* allow the investigators to study pharmacogenetic profiles.\n* allow the investigators to examine chromosome copy number variations.\n* allow the investigators to examine genomic methylation.\n* allow the investigators to quantify metabolomics/cytokines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals known or suspected of having a blood cancer or hematologic disorder\n* Individuals with presence of extramedullary disease\n* Capable of providing informed consent.\n\nExclusion Criteria:\n\n* Does not have a blood cancer or a hematologic disorder'}, 'identificationModule': {'nctId': 'NCT02435550', 'briefTitle': 'iCare for Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'iCare for Cancer Patients', 'orgStudyIdInfo': {'id': 'IRB201500073'}, 'secondaryIdInfos': [{'id': 'OCR14209', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute Myeloid Leukemia', 'description': 'Patients with acute myeloid leukemia will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.', 'interventionNames': ['Genetic: Molecular diagnostic testing']}, {'type': 'EXPERIMENTAL', 'label': 'Acute Lymphoblastic Leukemia', 'description': 'Patients with acute lymphoblastic leukemia will have blood, bone marrow aspirate , and saliva collected from them as part of routine care.', 'interventionNames': ['Genetic: Molecular diagnostic testing']}, {'type': 'EXPERIMENTAL', 'label': 'Myelodysplastic Syndrome', 'description': 'Patients with myeloplastic syndrome will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.', 'interventionNames': ['Genetic: Molecular diagnostic testing']}, {'type': 'EXPERIMENTAL', 'label': 'Myelofibrosis', 'description': 'Patients with myelofibrosis will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.', 'interventionNames': ['Genetic: Molecular diagnostic testing']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Myeloma', 'description': 'Patients with multiple myeloma will have blood, bone marrow aspirate, and saliva collected from them as part of routine care.', 'interventionNames': ['Genetic: Molecular diagnostic testing']}], 'interventions': [{'name': 'Molecular diagnostic testing', 'type': 'GENETIC', 'description': 'Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.', 'armGroupLabels': ['Acute Lymphoblastic Leukemia', 'Acute Myeloid Leukemia', 'Multiple Myeloma', 'Myelodysplastic Syndrome', 'Myelofibrosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Shands Cancer Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Christopher R. Cogle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cellworks Group Inc.', 'class': 'INDUSTRY'}, {'name': 'Gateway for Cancer Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}