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NCT01629745 Clinical Trial

Genetic Test in Detecting Minimal Residual Disease in Samples From Younger Patients Registered on the COG-AALL08B1 Trial

Leukemia Clinical Trial

Official title:
Feasibility of Minimal Residual Disease (MRD) Determination in Pediatric B-Lineage ALL Using Deep Sequencing of the Immunoglobulin Heavy Chain Locus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01629745
Other study ID # AALL12B6
Secondary ID COG-AALL12B6NCI-
Status Completed
Phase N/A
First received June 26, 2012
Last updated May 17, 2016
Start date June 2012
Est. completion date May 2016

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: Testing for minimal residual disease in blood samples from patients with acute lymphoblastic leukemia may help doctors plan better treatment.

PURPOSE: This research trial studies a genetic test in detecting minimal residual disease in samples from younger patients registered on COG-AALL08B1 trial.

Description:

OBJECTIVES:

- Assess the feasibility of minimal residual disease (MRD) determination in pediatric B-lineage acute lymphoblastic leukemia (ALL) using deep sequencing of the immunoglobulin heavy chain locus.

OUTLINE: Archived blood and tumor tissue samples are analyzed for MDR using deep sequencing of immunoglobulin heavy chain locus. MDR quantification results are then compared with the flow cytometry reference methods used in COG studies.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date May 2016
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 30 Years
Eligibility DISEASE CHARACTERISTICS:

- Samples from patients registered on the Children Oncology Group (COG)-AALL08B1 protocol and stored in the Hematopathology Laboratory at the University of Washington

- Pretreatment and after induction therapy samples

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• gene expression analysis

Other:
• flow cytometry

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of deep sequencing of the immunoglobulin heavy chain locus in determining MRD in B-lineage ALL No
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