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

Children's Oncology Group

Status: Active, not recruiting

Conditions: Childhood Malignant Neoplasm

Treatments: Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00082745

ALTE03N1 (Other Identifier)

U10CA180886 (U.S. NIH Grant/Contract)

UG1CA189955 (U.S. NIH Grant/Contract)

U10CA095861 (U.S. NIH Grant/Contract)

UG1CA189958 (U.S. NIH Grant/Contract)

CDR0000360708

COG-ALTE03N1

Details and patient eligibility

About

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.

Full 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 saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.

Enrollment: 3,885 estimated patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 saliva specimen) to the Coordinating Center at the University of Alabama at Birmingham 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
  • Ischemic stroke (IS)
  • Avascular necrosis (AVN)
  • Subsequent malignant neoplasm (SMN)

• CONTROLS: Submission of a blood specimen (or in certain cases a saliva specimen) to the Coordinating Center Laboratory at the University of Alabama at Birmingham 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 design

3,885 participants in 1 patient group

Observational (genetic analysis)

Description:

DNA from peripheral blood or saliva sample of patients is analyzed for the presence of polymorphisms in genes associated with an increased risk of late-occurring complications.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration