Leukemia Clinical Trial
Official title:
Validation of a Classifier for the Prediction of Risk of Relapse Using Single Cell Network Profiling (SCNP) Assays for Childhood AML
Verified date | May 2016 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Patients with confirmed non-M3 acute myeloid leukemia - Treated on COG-AAML03P1 or COG- AAML0531 protocols - Samples from COG-AAML0531 can come from either treatment arm, but these samples need to be independent from any patients who donated samples assayed in study COG-AAML11B2 - Patients with Down syndrome are excluded - Cryopreserved bone marrow mononuclear cell (BMMC) samples collected at diagnosis, prior to start induction therapy - Samples must have been cryopreserved at central lab within 3 days of draw at clinical site - Target of 10 X 10^6 cells frozen - Patients' clinical annotations required after unblinding PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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. | Up to 3 years | No |
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