Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
This is a prospective cohort study with the goal of obtaining fresh tumor biopsies and one
blood sample from patients with a confirmed histological or cytological diagnosis of cancer,
who are potential candidates for a phase I or II clinical trial at their local institution.
DNA from fresh tumor biopsies and from mononuclear blood cells will be subjected to targeted
and genome-wide sequencing to enable molecular characterization of tumors. Application of
genomic information by investigators will be captured. Archived tumor samples will be
requested from all patients. For patients with malignant ascites or pleural effusions, fluid
and tumor samples will be evaluated.
Observational Model: Cohort, Time Perspective: Prospective
Time from patient recruitment to final results ≤ 3 weeks in ≥ 90% of patients
Average and range of time (in weeks) that occur between study participants providing informed consent to the reporting of genomic results to the physician.
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
Lillian Siu, MD
Princess Margaret Hospital, Canada
Canada: Ethics Review Committee