Ontario-wide Cancer TArgeted Nucleic Acid Evaluation

Titre officiel

Ontario-wide Cancer TArgeted Nucleic Acid Evaluation

Sommaire:

D'importants progrès ont été réalisés dans le traitement du cancer, grâce à l'utilisation de thérapies ciblées. Toutefois, ce qui fonctionne pour un patient peut ne pas fonctionner avec un autre. Certains médicaments en cours de développement ciblent des molécules précises du corps dont on pense qu'elles jouent un rôle dans la maladie.

Les biomarqueurs, caractéristiques du cancer, pourraient renseigner sur le pronostic (p. ex. le bien-être des patients, tous traitements confondus) ou contribuer à prédire la sensibilité ou la résistance à une thérapie donnée.

Des échantillons tumoraux archivés (provenant de biopsies ou de prélèvements chirurgicaux antérieurs) fourniront des données sur les biomarqueurs du cancer de chaque patient. Les médecins pourraient ainsi trouver les essais cliniques portant sur de nouveaux médicaments convenant mieux aux patients à l'avenir, et orienter l'utilisation de traitements approuvés susceptibles de leur profiter.

L'autre objectif de cette étude consiste à créer un registre provincial des résultats ciblés d'analyse de séquençage des gènes qui sera accessible aux chercheurs sur le cancer. D'autres échantillons de tissus tumoraux et de sang prélevés sur tous les participants à l'étude seront également stockés dans une biobanque de l'Institut ontarien de recherche sur le cancer à des fins de recherche ultérieure.

L'étude cherchera aussi à associer ses données à d'autres bases de données sur la santé pour recueillir d'autres informations sur les soins dispensés aux patients, notamment les analyses médicales, les visites cliniques ou les procédures, à la fois avant et après la participation à cette étude. Le supplément d'information sur le lien entre la santé des patients et les séquences d'ADN pourrait donner de nouvelles perspectives sur le cancer et son traitement.

Description de l'essai

Primary Outcome:

  • Number of patients included in a province-wide registry of NGS panel-based testing results
  • Change in use of NGS panel-based testing in Ontario clinical genetic testing laboratories
  • Number of patients included in province-wide repository of genomically-characterized tumour tissue and blood samples and their utilization rates for future research
  • Change in rates of genomics based clinical research in Ontario
  • Utilization rates of province-wide genomically-characterized and clinically-annotated patient base in enrollment into specific research initiatives
  • Utilization rates of molecular profiling information provided to treating physicians in guiding future treatment decisions
Secondary Outcome:
  • Percentage of successful linkages between transferred study data and administrative databases
  • Concordance between administrative data and clinically abstracted data comparing variables using 2x2 concordance tables
A recent survey of clinical genetic testing laboratories for cancer diagnostics by the Molecular Oncology Advisory Committee for Cancer Care Ontario identified disparities in access and use patterns for next generation sequencing (NGS) across the province of Ontario. All fourteen responding laboratories indicated that NGS instruments were either currently being used for clinical testing, were in the validation stage, or that they were planning to purchase NGS instruments within the near future. Respondents were uncertain about what tests should be performed, how costing and reimbursement would be addressed by the provincial funding agency (e.g. individual tests vs. panels), and how to deal with informatics issues from NGS testing, such as storage, variant interpretation, and utilization over the long term. Given the increasing use of multi-gene somatic mutation testing in routine clinical cancer care (e.g. KRAS, NRAS, BRAF mutations in colorectal cancer, EGFR mutation and ALK translocation in non-small cell lung cancer, and BRAF, NRAS, and cKIT mutations in malignant melanoma), there is a need to expand the infrastructure for NGS panel testing in clinical laboratories. With a single payer provincial health care system, there is also an opportunity to develop a provincial-wide registry of NGS panel-based testing results and repository of genomically-characterized and clinically-annotated tumour tissues and blood samples to accelerate the development of additional "omic"-based tests for clinical use. This study will enroll patients with advanced, incurable solid tumours at selected Ontario hospitals receiving standard palliative treatment(s). Archival formalin-fixed paraffin embedded (FFPE) tumour tissue will be requested and undergo targeted panel sequencing. An additional FFPE tissue sample will be requested at the same time for future research purposes. Patients will also be asked to provide blood samples for future research. A selected number of genes will be annotated in a research report provided to their treating oncologist. In addition to the clinically reported variants, targeted NGS testing results for all tested genes will be captured in a clinical research database that can be accessed by the treating oncologist in a secure web-based portal. Following the reporting of targeted DNA sequencing results into the web-portal, remaining tumour DNA will be stored in the clinical testing laboratories. Blood samples collected at the time of consent and additional FFPE research blocks or slides collected for research will be transferred to a centralized biorepository maintained by the Ontario Tumour Bank (OTB) for more comprehensive analysis at the Princess Margaret (PM)-Ontario Institute for Cancer Research (OICR) Translational Genomics Laboratory (TGL). Blood will undergo standard germline DNA extraction and plasma processing for future circulating tumour DNA (ctDNA) and RNA (ctRNA) isolation at the PM-OICR TGL. Selected patient samples will be further characterized at the PM-OICR TGL for test development, additional sequencing, or discovery research. All patients will be asked to provide permission for data-sharing with other cancer researchers. The consent will also include a provision for review of patient health records through review of patient charts or administrative databases (i.e. Cancer Care Ontario New Drug Funding Program, Provincial Cancer Registry, etc.) to obtain addition information about time on drug treatments and survival.

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer