title: The PETALE study: Late adverse effects and biomarkers in childhood acute lymphoblastic leukemia survivors.
abstract: Childhood cancer survivorship issues represent an established public health challenge. Most late adverse effects (LAEs) have been demonstrated to be time and treatment dependent. The PETALE study is a multidisciplinary research project aiming to comprehensively characterize LAEs and identify associated predictive biomarkers in childhood acute lymphoblastic leukemia (cALL) survivors.
  
  
  
  cALL survivors treated at Sainte-Justine University Health Center with Dana-Farber Cancer Institution-ALL protocols 87-01 through 2005-01 were eligible. During Phase I of the study, the participants underwent comprehensive clinical, biologic, and psychosocial investigation targeting metabolic syndrome, cardiotoxicity, bone morbidity, neurocognitive problems, and quality of life issues. Whole-exome sequencing was performed for all participants. Subjects identified with an extreme phenotype during Phase I were recalled for additional testing (Phase II).
  
  
  
  Phase I included 246 survivors (recall rate 71.9%). Of those, 85 participants completed Phase II (recall rate 88.5%). Survivors agreeing to participate in Phase I (n = 251) were similar to those who refused (n = 31) in terms of relapse risk profile, radiotherapy exposure, and age at the time of study. Participants, however, tended to be slightly older at diagnosis (6.1 vs. 4.7 years old, P = 0.08), with a higher proportion of female agreeing to participate compared with males (93.2 vs. 86.5%, P = 0.07).
  
  
  
  The PETALE study will contribute to comprehensively characterize clinical, psychosocial, biologic, and genomic features of cALL survivors using an integrated approach. Expected outcomes include LAE early detection biomarkers, long-term follow-up guidelines, and recommendations for physicians and health professionals.
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Sophie
authors.initials: S
authors.lastname: Marcoux
authors.affiliation: Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Simon
authors.initials: S
authors.lastname: Drouin
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Caroline
authors.initials: C
authors.lastname: Laverdière
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Alos
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Gregor U
authors.initials: GU
authors.lastname: Andelfinger
authors.affiliation: Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Laurence
authors.initials: L
authors.lastname: Bertout
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Daniel
authors.initials: D
authors.lastname: Curnier
authors.affiliation: McGill University Health Center Research Institute, Montréal, Québec, Canada.
authors.forename: Matthias G
authors.initials: MG
authors.lastname: Friedrich
authors.affiliation: Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Ekaterini A
authors.initials: EA
authors.lastname: Kritikou
authors.affiliation: Université du Québec à Montréal (UQAM), Montréal, Québec, Canada.
authors.forename: Geneviève
authors.initials: G
authors.lastname: Lefebvre
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Emile
authors.initials: E
authors.lastname: Levy
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Sarah
authors.initials: S
authors.lastname: Lippé
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Valérie
authors.initials: V
authors.lastname: Marcil
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Marie-Josée
authors.initials: MJ
authors.lastname: Raboisson
authors.affiliation: Shriners Hospitals for Children, Montréal, Québec, Canada.
authors.forename: Frank
authors.initials: F
authors.lastname: Rauch
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.|Children's Hospital of Eastern Ontario (CHEO), Ottawa, Ontario, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Robaey
authors.affiliation: Université du Québec à Montréal (UQAM), Montréal, Québec, Canada.
authors.forename: Mariia
authors.initials: M
authors.lastname: Samoilenko
authors.affiliation: McGill University Health Center Research Institute, Montréal, Québec, Canada.
authors.forename: Chantal
authors.initials: C
authors.lastname: Séguin
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Serge
authors.initials: S
authors.lastname: Sultan
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Maja
authors.initials: M
authors.lastname: Krajinovic
authors.affiliation: Université de Montréal, Montréal, Québec, Canada.|Sainte-Justine University Health Center (SJUHC), Montréal, Québec, Canada.
authors.forename: Daniel
authors.initials: D
authors.lastname: Sinnett
mesh_terms: D000293:Adolescent; D000328:Adult; D014408:Biomarkers, Tumor / Q000378:metabolism*; D001847:Bone Diseases / Q000453:epidemiology / Q000209:etiology / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D005260:Female; D006331:Heart Diseases / Q000453:epidemiology / Q000209:etiology / Q000378:metabolism; D006801:Humans; D007223:Infant; D008297:Male; D024821:Metabolic Syndrome / Q000453:epidemiology / Q000378:metabolism; D019965:Neurocognitive Disorders / Q000453:epidemiology / Q000209:etiology / Q000378:metabolism; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000378:metabolism* / Q000401:mortality / Q000628:therapy*; D017741:Survivors
chemical_list: D014408:Biomarkers, Tumor
keywords: acute lymphoblastic leukemia; biomarkers; childhood cancer; late adverse effects; next-generation sequencing; survivorship