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

This study is currently recruiting participants.
Verified August 2017 by Children's Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT00082745
First Posted: May 19, 2004
Last Update Posted: August 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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.

Condition Intervention
Cancer Survivor Cardiovascular Complication Malignant Childhood Neoplasm Other: Laboratory Biomarker Analysis Other: Questionnaire Administration

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Key Adverse Events After Childhood Cancer

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

Primary Outcome Measures:
  • Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control) [ Time Frame: Up to 1 year ]
    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.

  • Frequency of mutations or polymorphisms in specific candidate genes in cases and controls [ Time Frame: Up to 1 year ]
    Allele frequencies will be estimated by the gene counting method, and the chi-square test will be used to check for departures from Hardy-Weinberg equilibrium.

  • Crude disease-exposure [ Time Frame: Up to 1 year ]
    The crude disease-exposure association will be determined by estimating the OR and its 95% confidence interval (CI). This will be done by univariate conditional logistic regression, to account for the matched design. The significance of the OR will be assessed by the Wald test. Backward stepwise regression procedures will be used to develop the final multivariate model and possible interactions will be examined. The fit of the model will be assessed by the logistic regression diagnostics procedure.


Biospecimen Retention:   Samples With DNA
peripheral blood or buccal sample

Estimated Enrollment: 8100
Study Start Date: March 2004
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of primary cancer at age 21 or younger meeting other criteria
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
  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): NCT00082745


  Show 155 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Smita Bhatia, MD MPH Children's Oncology Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00082745     History of Changes
Obsolete Identifiers: NCT00228787
Other Study ID Numbers: ALTE03N1
NCI-2011-03822 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ALTE03N1 ( Other Identifier: Children's Oncology Group )
CDR0000360708 ( Other Identifier: ClinicalTrials.gov )
ALTE03N1 ( Other Identifier: Children's Oncology Group )
ALTE03N1 ( Other Identifier: CTEP )
U10CA095861 ( U.S. NIH Grant/Contract )
U10CA180886 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2004
First Posted: May 19, 2004
Last Update Posted: August 21, 2017
Last Verified: August 2017