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

  • STATUS
    Recruiting
  • participants needed
    3885
  • sponsor
    Children's Oncology Group
Updated on 30 August 2020
Investigator
Steven K. Bergstrom
Primary Contact
Kaiser Permanente-Oakland (9.6 mi away) Contact
+62 other location
cancer treatment

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, avascular necrosis, 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.

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.

Details
Treatment laboratory biomarker analysis, questionnaire administration
Clinical Study IdentifierNCT00082745
SponsorChildren's Oncology Group
Last Modified on30 August 2020

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Eligibility

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Inclusion Criteria

Is your age less than or equal to 21 yrs?
Gender: Male or Female
Do you have any of these conditions: Malignant Childhood Neoplasm or Cardiovascular Complication or Cancer Survivor or Childhood Malignant Neoplasm?
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
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