Study of Late-Occurring Complications in Childhood Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00082745
First received: May 14, 2004
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

This clinical trial is studying 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 Complications
Hematopoietic/Lymphoid Cancer
Unspecified Childhood Solid Tumor, Protocol Specific
Other: questionnaire administration
Other: laboratory biomarker analysis

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

Resource links provided by NLM:


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: 1 year ] [ Designated as safety issue: Yes ]
    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: 1 year ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

peripheral blood or buccal sample


Estimated Enrollment: 6900
Study Start Date: March 2004
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational

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, such as cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, vascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasms.

Patients also complete a questionnaire detailing family history and health history.

Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative 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 DNA and 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: This is a multicenter study.

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, such as cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasms.

Patients also complete a questionnaire detailing family history and health history.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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:

  • 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 WBC is > 2,000
  • Written informed consent from the patient and/or the patient's legally authorized guardian, obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services
  • 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
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: NCT00082745

  Show 143 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Smita Bhatia, MD MPH Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00082745     History of Changes
Obsolete Identifiers: NCT00228787
Other Study ID Numbers: ALTE03N1, NCI-2011-03822, COG-ALTE03N1, CDR0000360708, ALTE03N1, ALTE03N1, U10CA095861
Study First Received: May 14, 2004
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 21, 2014