Groupe d'Etude en Oncologie du Quebec

Titre	Key Adverse Events After Childhood Cancer.
Protocole ID	ALTE03N1
ClinicalTrials.gov ID	NCT00082745
Type(s) de cancer	Pédiatrique divers
Phase	Autres
Institution	CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
Ville	Montréal
Investigateur(trice) principal(e)	Dre Caroline Laverdière
Coordonnateur(trice)	Linda Hershon 514-345-4931 poste 5899
Statut	Actif en recrutement
Critètes d'éligibilité	DISEASE CHARACTERISTICS: Diagnosis of primary cancer at age 21 or younger No prior history of allogeneic (non-autologous) hematopoietic cell transplant 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: 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: 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 Myocardial infarction (closed to accrual as of 6/5/06) Ischemic stroke Avascular necrosis Subsequent malignant neoplasm
Critètes d'exclusion

Groupe d'étude en oncologie du Québec