Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00082745 : Study of Late-Occurring Complications in Childhood Cancer Survivors
PhaseN/A
AgesMin: N/A Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00082745      |      Link to official Clinicaltrials.gov listing
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