NCT00896766

Brief Summary

RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at lymphoblasts in young patients with high-risk acute lymphoblastic leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

10 years

First QC Date

May 9, 2009

Last Update Submit

May 13, 2016

Conditions

Leukemia

Keywords

childhood acute lymphoblastic leukemia in remissionB-cell childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (7)

  • Identification of regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts using Affymetrix GeneChip Mapping 500K array sets

  • Identification of regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays. (Expansion project)

  • Gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus 2.0 arrays

  • Global expression of microRNAs in leukemic lymphoblasts using microRNA gene chips

  • Epigenomic profiles using the HpaII tiny fragment Enrichment by Ligation-mediated PCR (HELP) assay. (Expansion project)

  • Prioritization of candidate genes and genomic regions for resequencing using array-generated gene expression data and data for CNAs

  • Identification of genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing

Interventions

loss of heterozygosity analysisGENETIC
microarray analysisGENETIC
polymorphism analysisGENETIC
tumor replication error analysisGENETIC

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Targets for High-Risk Pediatric Acute Lymphoblastic Leukemia

DISEASE CHARACTERISTICS: * Diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL) * High-risk disease * Participation in clinical trial COG-P9906 required (pilot project) * In complete remission * Consented to future studies using banked tissue specimens * Participation in clinical trial and COG-AALL03B1 and linked therapeutic studies COG-AALL0232 and COG- AALL0331(expansion project) * Experienced a bone marrow relapse within 36 months of initial diagnosis * Consented to future studies using banked tissue specimens * Have matched ALL blast and germline specimens * Demographic, clinical and pathologic data elements for these biospecimens available 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

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

Microarray AnalysisAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesDNA FingerprintingGenetic TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Stephen P. Hunger, MD

    Children's Hospital Colorado Center for Cancer and Blood Disorders

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2006

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

US(1)