An observational study in Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 and Adult Acute Promyelocytic Leukemia With PML-RARA, sponsored by Children's Oncology Group. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-07-14.
Sponsored by Children's Oncology Group · Observational
This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PRIMARY OBJECTIVES:
I. Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease.
II. Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered.
OUTLINE:
Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.
5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
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Inclusion Criteria:
DNA samples available from patients meeting the following criteria:
Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.
Other: Laboratory Biomarker Analysis
Correlative studies
Differences in induction outcome, dichotomized into complete remission or no remission
Assessed with Fisher's exact test.
Time frame: Up to 8 years
Differences in induction outcome, dichotomized into complete remission or no remission
Assessed with Pearson's chi square statistic test
Time frame: Up to 8 years
Differences in overall survival
Evaluated using the log rank statistic.
Time frame: Up to 8 years
Disease-free survival (DFS)
Evaluated using the log rank statistic.
Time frame: Time from the end of induction to relapse or death, assessed up to 8 years
Relapse-free survival
Evaluated using the logrank statistic.
Time frame: Time from the end of induction to marrow relapse or death from progressive disease, censoring on deaths from other causes, assessed up to 8 years
Etiology of leukemia: Chi square test
Chi square test will be used to determine the differences in distribution of genotypes between cases and controls.
Time frame: Up to 8 years
Etiology of leukemia: Fisher's exact test
Fisher's exact test will be used to determine the differences in distribution of genotypes between cases and controls.
Time frame: Up to 8 years
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group