Biomarker Study in Bone Marrow Samples From Patients With T-Cell Acute Lymphoblastic Leukemia

NCT01295476 | Completed

• 4 other identifiers: AALL10B1COG-AALL10B1CDR0000695252NCI-2011-02848
• Study Type: observational
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is studying biomarkers in bone marrow samples from patients with T-cell acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

adult acute lymphoblastic leukemia in remission; childhood acute lymphoblastic leukemia in remission; recurrent adult acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia; T-cell childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Association between induction failure status predicted by 116-member genomic classifier and actual induction therapy outcome observed on COG study AALL0434

Interventions

gene expression analysis GENETIC

microarray analysis GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed T-cell acute lymphoblastic leukemia

DISEASE CHARACTERISTICS: * Newly diagnosed T-cell acute lymphoblastic leukemia * Cryopreserved bone marrow from the Children Oncology Group (COG) Cell Bank of patients enrolled on COG-AALL03B1 and COG-AALL0434, including the following: * 30 samples from patients who had \> 25% bone marrow blasts at day 29 (induction failure \[IF\] cases) * Samples of cases of bone marrow and/or CNS relapse occurring within the first 18 months of treatment * Random samples of 105 non-IF cases who achieved remission at the end of induction therapy (at least 18 months) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Bone Marrow

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Gene Expression Profiling; Microarray Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures

Study Officials

• Stuart S. Winter, MD

  University of New Mexico Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 14, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 18, 2016

Record last verified: 2016-05