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OpenTrials
Completed

NCT Number: NCT01533168

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

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–30 year

Sex eligibility

All sexes

Study type

Observational

About this study

OBJECTIVES:

  • To identify and characterize changes in clonal populations of B cells in children with acute lymphoblastic leukemia (ALL) at diagnosis and Day 29 of induction.
  • To define the ability of this technology to reclassify patients as minimal residual disease (MRD) positive at Day 29 of induction.
  • To determine whether more sensitive detection of MRD at Day 29 would have clinical prognostic value in children with ALL.

OUTLINE: DNA extracted from diagnostic cells are analyzed for immunoglobulin heavy chain variable region by next-generation sequencing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cytogenetic analysis

Genetic

nucleic acid sequencing

Genetic

diagnostic laboratory biomarker analysis

Other

laboratory biomarker analysis

Other

medical chart review

Other

Primary outcomes

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

  2. Reclassification of patients as MRD positive at day 29

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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Next-Generation Sequencing of Immunoglobulin Heavy Chain Variable Region to Identify Previously Undetectable Minimal Residual Disease in Children With Acute Lymphoblastic Leukemia With Prognostic Significance

Important dates

Study start
2012
Primary completion
2016
First posted
Feb 15, 2012
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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