Titre |
Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy |
Protocole ID |
ALTE11C2 |
ClinicalTrials.gov ID |
NCT01790152 |
Type(s) de cancer |
Pédiatrique divers |
Phase |
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Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
HOPITAL DE MONTREAL POUR ENFANTS
1001 boul. Décarie , Montréal, QC, H4A 3J1
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Ville |
Montréal |
Investigateur(trice) principal(e) |
Dre Sharon Abish
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Coordonnateur(trice) |
Laurie Cleophat
514-412-4400 poste 23807
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Statut |
Actif en recrutement |
Critètes d'éligibilité |
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Patients with T-cell leukemia/lymphoma or Hodgkin lymphoma enrolled on Pediatric Oncology Group (POG) 9404, 9425, 9426.
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STRATUM I: Alive and in continuous first complete remission from their original cancer (T-cell leukemia/lymphoma [POG 9404] or Hodgkin lymphoma [POG 9425/9426])
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STRATUM I: Not have been diagnosed with any subsequent malignancy, with the exception of non-melanomatous skin cancer(s); patients with history of only subsequent non-melanomatous skin cancers remain eligible
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STRATUM I: All patients and/or their parents or legal guardians must sign a written informed consent
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Among patients who have relapsed or have experienced a subsequent malignancy other than non-melanomatous skin cancer since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's [COG's] Statistics and Data Center [SDC] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse/subsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)
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STRATUM II: Alive, but have experienced relapse of their original cancer and/or have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis
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STRATUM II: All patients and/or their parents or legal guardians must sign a written informed consent
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Critètes d'exclusion |
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