NCT01284010

Brief Summary

RATIONALE: Studying samples of blood and bone marrow 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 blood and bone marrow samples from patients with acute lymphoblastic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Typical duration 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

First Submitted

Initial submission to the registry

January 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

3.6 years

First QC Date

January 25, 2011

Last Update Submit

February 19, 2020

Conditions

Leukemia

Keywords

adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (5)

  • complete remission rate

    Up to 7 Years

  • disease free survival

    Up to 7 Years

  • cumulative incidence of relapse

    Up to 7 years

  • overall survival

    Up to 7 years

  • event-free survival

    Up to 7 years

Study Arms (1)

Group 1

Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients.

Genetic: DNA analysisGenetic: fluorescence in situ hybridizationGenetic: gene expression analysisGenetic: microarray analysisGenetic: mutation analysisGenetic: polymerase chain reactionOther: laboratory biomarker analysis

Interventions

DNA analysisGENETIC
Group 1
fluorescence in situ hybridizationGENETIC
Group 1
gene expression analysisGENETIC
Group 1
microarray analysisGENETIC
Group 1
mutation analysisGENETIC
Group 1
polymerase chain reactionGENETIC
Group 1
laboratory biomarker analysisOTHER
Group 1

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute lymphoblastic leukemia (ALL) patients treated on protocols CALGB 9511, 19802, 10001, 10102, and 10403, and who have been registered on the companion study CALGB 9665 (The CALGB Leukemia Tissue Bank)

You may qualify if:

  • Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10001, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

In Situ Hybridization, FluorescenceGene Expression ProfilingMicroarray AnalysisPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationMicrochip Analytical ProceduresNucleic Acid Amplification Techniques

Study Officials

  • James Downing, MD

    St. Jude Children's Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 26, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

US(1)