TITRE Effets secondaires importants suite à un cancer chez l'enfant
PROTOCOLE ID ALTE03N1
CLINICAL TRIAL.gov ID NCT00082745
TYPE(S) DE CANCER Pédiatrique divers
PHASE Autres
TYPE D'ÉTUDE
INSTITUTION CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
3175 Chemin de la Côte Sainte-Catherine
(514) 345-4931
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Caroline Laverdière
COORDONATEUR(RICE) Linda Hershon
linda.hershon@recherche-ste-justine.qc.ca
514-345-4931 poste 5899
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)

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
CRITÈRES D'EXCLUSION