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

Study ID
ALTE03N1

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • UT Southwestern Ambulatory Services
  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Beverly Kleiber
214-456-6484
beverly.kleiber@childrens.com

Principal Investigator
Patrick Leavey, M.D.

Official Title

Key Adverse Events After Childhood Cancer

Brief Overview


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.

Summary


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.

Participant Eligibility


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