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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000711851 | Other Identifier | Clinical Trials.gov | |
| COG-AAML11B2 | Other Identifier | Children's Oncology Group | |
| NCI-2011-03465 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: A screening test, such as My Profile Pediatric Assay, may help doctors predict a patient's risk of relapse and plan better treatment for acute myeloid leukemia.
PURPOSE: This clinical trial is studying using the My Profile Pediatric Assay to see how well it works in predicting risk of relapse in bone marrow cell samples from younger patients with acute myeloid leukemia.
OBJECTIVES:
Primary
Secondary
OUTLINE: Archived bone marrow mononuclear cells are analyzed by single cell network profile assay, the My Profileâ„¢ AML Risk of Relapse Assay. Molecular markers analyzed include Flt3-ITD, NPM1, and MRA. Results are then correlated with each patient's clinical data including patient's age, race/ethnic background, gender, treatment received, and outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Correlative studies | Archived bone marrow mononuclear cells are analyzed by single cell network proteomic profiling assay, the My Profileâ„¢ AML Risk of Relapse Assay. Molecular markers analyzed include Flt3-ITD, NPM1, and MRA. Results are then correlated with each patient's clinical data including patient's age, race/ethnic background, gender, treatment received, and outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnostic laboratory biomarker analysis | Other | Correlative studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the receiver operating characteristic (ROC) curve of continuous score from the pre-specified classifier in predicting relapse after complete response to cytarabine- based induction chemotherapy | A logistic regression model and area under the ROC curve for the model will be tested for significance against a null value of 0.5. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous score from the pre-specified classifier as a predictor of relapse after response to induction chemotherapy | A gate-keeper strategy will be applied to control the experiment-wise type I error rate at 0.05. The null hypothesis will be tested using a likelihood ratio test that will compare the likelihood for a full (LF) and a reduced (LR) logistic regression model of relapse (early relapse vs continuous complete response), where the full model will include the covariates and the continuous score from the pre-specified classifier and the reduced model will include only the covariates. |
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DISEASE CHARACTERISTICS:
Patients with confirmed non-M3 acute myeloid leukemia
Treated on COG-AAML03P1 or COG- AAML0531 protocols
Patients with Down syndrome are excluded
Cryopreserved bone marrow mononuclear cell (BMMC) samples collected at diagnosis, prior to start induction therapy
Patients' clinical annotations required after unblinding
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients with confirmed non-M3 acute myeloid leukemia treated on COG-AAML03P1 or COG-AAML0531 protocols
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| Name | Affiliation | Role |
|---|---|---|
| Norman J. Lacayo, MD | Stanford University | Principal Investigator |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015472 | Leukemia, Eosinophilic, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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bone marrow
| Up to 3 years |
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |