Clinical Trials /

Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

NCT00082745

Description:

This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Related Conditions:
  • Cancer
Recruiting Status:

Active, not recruiting

Trial Eligibility

Document

Title

  • Brief Title: Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
  • Official Title: Key Adverse Events After Childhood Cancer

Clinical Trial IDs

  • ORG STUDY ID: ALTE03N1
  • SECONDARY ID: NCI-2011-03822
  • SECONDARY ID: COG-ALTE03N1
  • SECONDARY ID: CDR0000360708
  • SECONDARY ID: ALTE03N1
  • SECONDARY ID: ALTE03N1
  • SECONDARY ID: U10CA180886
  • SECONDARY ID: U10CA095861
  • SECONDARY ID: UG1CA189955
  • SECONDARY ID: UG1CA189958
  • NCT ID: NCT00082745
  • NCT ALIAS: NCT00228787

Conditions

  • Cancer Survivor
  • Cardiovascular Complication
  • Childhood Malignant Neoplasm

Purpose

This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To identify key adverse events developing in patients (cases) with a primary cancer
      diagnosed at age 21 or younger.

      II. To characterize the key adverse events with respect to the nature of the primary
      malignancy (pathology, stage) and coded details of the therapeutic protocol.

      III. To identify treatment-related and demographic risk factors through a direct comparison
      of the case-group and controls identified from the remaining patients with the same primary
      diagnosis.

      IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in
      cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid
      (RNA) from the cases and controls.

      V. To explore the role and nature of gene-environment interaction in the development of key
      adverse events.

      OUTLINE:

      DNA and RNA from peripheral blood or buccal sample of patients is analyzed for the presence
      of polymorphisms in candidate genes associated with an increased risk of late-occurring
      complications.
    

Trial Arms

NameTypeDescriptionInterventions
Ancillary-Correlative (genetic analysis)DNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  ELIGIBILITY CRITERIA - CASES
    
              -  Diagnosis of primary cancer at age 21 or younger, irrespective of current age
    
              -  No prior history of allogeneic (non-autologous) hematopoietic cell transplant
    
              -  Development of one of the following key adverse events at any time following
                 initiation of cancer therapy:
    
                   -  Cardiac dysfunction; please note: case enrollment has been closed due to
                      achievement of target accrual
    
                   -  Ischemic stroke (IS)
    
                   -  Subsequent malignant neoplasm (SMN)
    
                   -  Avascular necrosis (AVN); please note: case enrollment has been closed due to
                      achievement of target accrual
    
              -  Submission of a blood specimen (or in certain cases a buccal cell specimen) to the
                 Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per
                 the requirements; please note: if a patient is currently receiving active cancer
                 treatment, it is preferable to obtain the blood sample at a time when the patient's
                 white blood cell (WBC) is > 2,000
    
              -  Written informed consent from the patient and/or the patient?s legally authorized
                 guardian
    
              -  In active follow up by a COG institution; active follow up will be defined as date of
                 last visit or contact by a COG institution within the past 24 months; any type of
                 contact, including contact specifically for participation in ALTE03N1, qualifies as
                 active follow-up; please note: treatment on a COG (or legacy group) therapeutic
                 protocol for the primary cancer is NOT required
    
              -  ELIGIBILITY CRITERIA - CONTROLS
    
              -  CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age
    
              -  CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell
                 transplant
    
              -  CONTROLS: No clinical evidence of any of the following key adverse events:
    
                   -  Cardiac dysfunction (CD); please note: if a patient is currently receiving active
                      cancer treatment, it is preferable to obtain the blood sample at a time when the
                      patient's WBC is > 2,000
    
                   -  Myocardial infarction (MI)
    
                   -  Ischemic stroke (IS)
    
                   -  Avascular necrosis (AVN)
    
                   -  Subsequent malignant neoplasm (SMN)
    
              -  CONTROLS: Submission of a blood specimen (or in certain cases a buccal cell specimen)
                 to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital
                 as per the requirements
    
              -  CONTROLS: Written informed consent from the patient and/or the patient?s legally
                 authorized guardian
    
              -  CONTROLS: In active follow up by a COG institution; active follow up will be defined
                 as date of last visit or contact by a COG institution within the past 24 months; any
                 type of contact, including contact specifically for participation in ALTE03N1,
                 qualifies as active follow-up; please note: treatment on a COG (or legacy group)
                 therapeutic protocol for the primary cancer is NOT required
          
    Maximum Eligible Age:21 Years
    Minimum Eligible Age:N/A
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)
    Time Frame:Up to 1 year
    Safety Issue:
    Description:Epidemiological, clinical and laboratory variables will be tested for their association with key adverse events. McNemar?s test for paired data will be used to compare the unmatched general characteristics of cases and controls.

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Recruiting
    Lead Sponsor:Children's Oncology Group

    Last Updated