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Clinical Trials (PDQ®)

Study of Late-Occurring Complications in Childhood Cancer Survivors

Basic Trial Information
Trial Description
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Natural history/EpidemiologyActive21 and under at diagnosis, any age at study entryNCI, OtherALTE03N1
NCI-2011-03822, COG-ALTE03N1, CDR0000360708, U10CA095861, NCT00082745

Trial Description


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.

Further Study Information


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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

Smita Bhatia, MD MPHPrincipal Investigator

Trial Sites

New Jersey
  New Brunswick
 Saint Peter's University Hospital
 Stanley Calderwood Ph: 732-745-8600ext6163

See All Trial Sites

Link to the current record.
NLM Identifer NCT00082745 processed this data on March 03, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to

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