Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia

NCT01533168 | Completed

• 4 other identifiers: AALL12B1COG-AALL12B1CDR0000724799NCI-2012-00246
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Testing for minimal residual disease in cell samples from patients with acute lymphoblastic leukemia may help doctors plan better treatment. PURPOSE: This research trial studies a genetic test in identifying previously undetectable minimal residual disease in cell samples from younger patients with acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

childhood acute lymphoblastic leukemia in remission; recurrent childhood acute lymphoblastic leukemia; B-cell childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (3)

• Identification and characterization of changes in clonal populations of B cells in children with ALL

• Reclassification of patients as MRD positive at day 29

• Higher sensitivity detection that allow the stratification of the MRD population into 2 groups with lower and higher likelihood of relapse

Interventions

cytogenetic analysis GENETIC

nucleic acid sequencing GENETIC

diagnostic laboratory biomarker analysis OTHER

laboratory biomarker analysis OTHER

medical chart review 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

Patients With Acute Lymphoblastic Leukemia

DISEASE CHARACTERISTICS: * Samples from patients enrolled on COG-AALL0232 with standard-risk (SR) or high-risk (HR) acute lymphoblastic leukemia (ALL) with varying levels of MRD and relapse * Diagnostic cells and Day 29 cells from patients that have not relapsed and are 5 years from diagnosis on protocol COG-AALL0232 * Diagnostic cells and Day 29 cells from patients that are matched for age, sex, initial white blood cell (WBC) count, and cytogenetics that have relapsed PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

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

cell samples

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cytogenetic Analysis; Base Sequence

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)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Norman J. Lacayo, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 15, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05