Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 8:58 AM
Study NCT ID:
NCT01385150
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2011-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015471', 'term': 'Leukemia, Basophilic, Acute'}, {'id': 'D015472', 'term': 'Leukemia, Eosinophilic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}], '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': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002853', 'term': 'Chromatography, Liquid'}, {'id': 'D013058', 'term': 'Mass Spectrometry'}], 'ancestors': [{'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-18', 'studyFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2011-06-28', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of serum 2HG in all samples without an IDH mutation', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Relationship between 2HG level and survival outcomes', 'timeFrame': '1 day'}]}, 'conditionsModule': {'keywords': ['adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'untreated adult acute myeloid leukemia', 'adult acute basophilic leukemia', 'adult acute eosinophilic leukemia', 'adult erythroleukemia (M6a)', 'adult pure erythroid leukemia (M6b)', 'adult acute minimally differentiated myeloid leukemia (M0)', 'adult acute monoblastic leukemia (M5a)', 'adult acute monocytic leukemia (M5b)', 'adult acute myeloblastic leukemia with maturation (M2)', 'adult acute myeloblastic leukemia without maturation (M1)', 'adult acute myelomonocytic leukemia (M4)'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and lean more about biomarkers related to cancer.\n\nPURPOSE: This research study is studying biomarkers in blood samples from patients with acute myeloid leukemia.', 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* To determine if serum 2-hydroxyglutarate (2HG) is only detected in acute myeloid leukemia (AML) patients with isocitrate dehydrogenase (IDH) mutations.\n\nSecondary\n\n* To determine if the level of serum 2HG impacts leukemia-free survival (LFS).\n* To determine if the level of serum 2HG impacts overall survival (OS).\n* To determine if serum 2HG is undetectable at the time of documented clinical remission (CR) in IDH-mutated patients.\n\nOUTLINE: Archived serum samples are analyzed for 2-hydroxyglutarate expression by reverse-phase liquid chromatography coupled to mass spectrometry. Results are then compared with presence or absence of an IDH mutation, patients' clinical outcome, as well as age, sex, white blood cell count at diagnosis, platelet count, bone marrow blast percentage at diagnosis, circulating (serum) percentage at diagnosis, cytogenetic risk group, presence of FLT3, NPMN1, and/or TET2 mutations, specific IDH mutation, and randomization treatment group allocation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Samples from patients enrolled on E1900 from whom samples were submitted for research', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Morphologically confirmed acute myeloid leukemia (AML)\n\n * Newly diagnosed with AML\n * Serum samples from patients enrolled on the ECOG-1900 clinical trial between 2002 and 2008\n * Patients with or without isocitrate dehydrogenase (IDH) mutations\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Received 2 different doses of standard induction chemotherapy on ECOG-1900'}, 'identificationModule': {'nctId': 'NCT01385150', 'briefTitle': 'Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': 'CDR0000702952'}, 'secondaryIdInfos': [{'id': 'ECOG-E1900T8'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'mutation analysis', 'type': 'GENETIC'}, {'name': 'protein analysis', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'liquid chromatography', 'type': 'OTHER'}, {'name': 'mass spectrometry', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Courtney DiNardo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}