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

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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, U10CA180886, NCT00082745

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

  • National Cancer Institute
Smita Bhatia, MD MPH, Principal Investigator

Trial Sites

U.S.A.

New Jersey
New Brunswick

Saint Peter's University Hospital

Stanley Calderwood
Ph: 732-745-8600ext6163
Email: kcovert@saintpetersuh.com

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00082745
ClinicalTrials.gov processed this data on April 02, 2015

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