NCT01119586

Brief Summary

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
2.7 years until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2.8 years

First QC Date

May 6, 2010

Last Update Submit

July 7, 2016

Conditions

Leukemia

Keywords

B-cell adult acute lymphoblastic leukemiaB-cell childhood acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (2)

  • Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis

  • Correlation between high-risk acute lymphoblastic leukemia with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation

Interventions

DNA analysisGENETIC
genetic linkage analysisGENETIC
microarray analysisGENETIC
nucleic acid sequencingGENETIC
polymerase chain reactionGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age1 Year - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients With High-Risk Acute Lymphoblastic Leukemia

DISEASE CHARACTERISTICS: * Newly diagnosed with high-risk B-precursor acute lymphoblastic leukemia * Matched patients non-tumor and blast DNA samples * Enrolled on COG-P9906 or COG-AALL0232 protocols * Cohort of random pediatric DNA samples extracted from newborn infants' blood spots from the State of Missouri PATIENT CHARACTERISTICS: * Newborn infants from the state of Missouri 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

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Leukemia

Interventions

Genetic LinkageMicroarray AnalysisBase SequencePolymerase Chain ReactionAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Genetic PhenomenaMicrochip Analytical ProceduresInvestigative TechniquesMolecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresNucleic Acid Amplification TechniquesGenetic TechniquesDNA Fingerprinting

Study Officials

  • Todd E. Druley, MD

    St. Louis Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 7, 2010

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-07