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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00897507
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Leukemia Genetic: polymorphism analysis

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.


Study Design

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Single Nucleotide Polymorphisms and Relapse Risk in Standard Risk ALL
Study Start Date : March 2005
Estimated Primary Completion Date : January 2100
Estimated Study Completion Date : January 2100


Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Role of single nucleotide polymorphisms (SNPs) in determining response to therapy [ Time Frame: length of study ]

Secondary Outcome Measures :
  1. 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 ]
  2. SNPs role in drug metabolizing enzymes and the development of veno-occlusive disease in patients enrolled on CCG-1952 [ Time Frame: length of study ]
  3. Interactions between genotypes and other risk factors for treatment response [ Time Frame: length of study ]
  4. Prediction of treatment response and toxicity utilizing genetic information and clinical data [ Time Frame: length of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897507


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Richard Aplenc, MD, MSCE Children's Hospital of Philadelphia
More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00897507     History of Changes
Other Study ID Numbers: AALL04B2
COG-AALL04B2 ( Other Identifier: Children's Oncology Group )
CDR0000371580 ( Other Identifier: Clinical Trials.gov )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

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

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