Clinical Trials

Study of Late-Occurring Complications in Childhood Cancer Survivors

Location:

Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES:

- Identify key late-occurring complications, specifically, 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 neoplasm, in childhood cancer survivors.

- Correlate key late-occurring complications with pathology and staging of the primary malignancy and therapeutic treatment protocol details in these patients.

- Identify treatment-related and demographic risk factors by comparing patients who develop late-occurring complications (case group) vs those with the same primary malignancy who do not develop late-occurring complications (control group).

- Compare the frequency of mutations or polymorphisms in specific candidate genes in both the case and control groups using constitutional DNA and RNA from both groups.

- Explore the role and nature of gene-environment interaction in the development of late-occurring complications in these patients.

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.

PROJECTED ACCRUAL: A total of 6,900 patients (1,725 with late-occurring complications [case group] and 5,175 without late-occurring complications [control group] [myocardial infarction patients closed to accrual as of 6/5/06, avascular necrosis patients closed to accrual as of 11/26/08, cardiac dysfunction patients closed to accrual as of 4/17/09]) will be accrued for this study.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- Diagnosis of primary cancer at age 21 or younger

- In active follow-up by a Children's Oncology Group (COG) institution

- Date of last visit or contact by a COG institution within the past 24 months

- Case group

- Development of one of the following key adverse events after initiation of prior cancer therapy:

- Cardiac dysfunction, meeting 1 of the following criteria (closed to accrual as of 4/17/09):

- Symptomatic cardiac dysfunction, including current or previous diagnosis of congestive heart failure based on any of the following clinical criteria:

- Pulmonary and/or peripheral edema

- Dyspnea

- Orthopnea

- Fatigue

- Hepatomegaly

- Asymptomatic cardiac dysfunction

- Ejection fraction < 40% on echocardiogram OR MUGA and/or fractional shortening < 28% on echocardiogram without clinical symptoms

- Myocardial infarction, meeting 1 of the following criteria (closed to accrual as of 6/5/06):

- Definite ECG changes

- Typical, atypical, or inadequately described symptoms AND probable ECG, AND abnormal enzymes, including creatine kinase MB

- Typical symptoms AND abnormal enzymes, including creatine kinase MB, AND ischemic ECG, non-codable ECG, or ECG not available

- Ischemic stroke, meeting the following criteria:

- Fixed neurological deficit lasting more than 24 hours

- Confirmed by CT scan or MRI within 7 days of onset of symptoms

- No subarachnoid or intracerebral hemorrhage, transient ischemic attacks, or amaurosis fugax

- Avascular necrosis, meeting the following criteria (closed to accrual as of 11/26/08):

- Clinical symptoms of joint pain, joint stiffness, or decreased range of motion

- Confirmed by plain radiographs, CT scan, MRI, or bone scan

- Subsequent malignant neoplasm, meeting the following criteria:

- Histologically distinct neoplasm developing in patients treated for a primary cancer

- Confirmed by an institutional pathology report

- Control group

- No clinical evidence of any of the following:

- 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)

- Subsequent malignant neoplasm

PATIENT CHARACTERISTICS:

Age

- 21 and under at diagnosis, any age at study entry

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- See Disease Characteristics

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No prior allogeneic (non-autologous) hematopoietic cell transplant

Last updated: 04/05/2011

NCT ID:

NCT00082745