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DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00897507
First received: May 9, 2009
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment

PURPOSE: This laboratory study is looking at DNA in tumor tissue samples from young patients with acute lymphoblastic leukemia.


Condition Intervention
Leukemia
Genetic: polymorphism analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Role of single nucleotide polymorphisms (SNPs) in determining response to therapy [ Time Frame: length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the association between SNPs and treatment outcome and toxicity in patients enrolled on CCG-1891 vs CCG-1952 [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • SNPs role in drug metabolizing enzymes and the development of veno-occlusive disease in patients enrolled on CCG-1952 [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Interactions between genotypes and other risk factors for treatment response [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Prediction of treatment response and toxicity utilizing genetic information and clinical data [ Time Frame: length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: March 2005
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the role of single nucleotide polymorphisms (SNPs) in determining response to therapy in pediatric patients with acute lymphoblastic leukemia.

Secondary

  • Compare the association between SNPs and treatment outcome and toxicity in patients enrolled on protocol CCG-1891 vs protocol CCG-1952.
  • Determine the role of SNPs in drug metabolizing enzymes and the development of veno-occlusive disease in patients enrolled on CCG-1952.
  • Evaluate interactions between genotypes and other risk factors for treatment response in these patients.
  • Determine predictive models utilizing genetic information and clinical data to predict treatment response and toxicity in these patients.

OUTLINE: Tumor tissue samples undergo genotype assessment on the Pyrosequencing platform. Contingency tables and X^2 test performs a univariate analysis of the risk of relapse and genotype, and multivariable analyses using logistic regression. Cox proportional hazards evaluate the risk of relapse given genotype and other confounders. Genotype patterning, classification and regression trees, and multifactor dimensionality reduction evaluates for patterns of single nucleotide polymorphisms associated with toxicity and relapse risk.

PROJECTED ACCRUAL: A total of 800 patients (200 with relapsed disease and 600 without relapsed disease) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients with acute lymphoblastic leukemia

Criteria

DISEASE CHARACTERISTICS:

  • Enrolled in clinical trial CCG-1891 or CCG-1952

PATIENT CHARACTERISTICS:

Age

  • Under 18

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897507

Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Richard Aplenc, MD, MSCE Children's Hospital of Philadelphia
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00897507     History of Changes
Other Study ID Numbers: AALL04B2, COG-AALL04B2, CDR0000371580
Study First Received: May 9, 2009
Last Updated: July 31, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
childhood acute lymphoblastic leukemia in remission
recurrent childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 20, 2014