This research is being done to find out what types of gene mutations are present in people with cancer. This study is designed to help researchers and doctors understand more about cancer. With this information, doctors may have a better idea as to which cancer treatments are most appropriate for certain patients. The information will also help researchers find out the how to identify genes in cancers from biopsies and blood samples and how to use this information to help doctors and patients make treatment decisions.
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.
Study Type
OBSERVATIONAL
Enrollment
50
Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
Princess Margaret Hospital
Toronto, Ontario, Canada
Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients
Average and range of time (in calendar days) that occurred between study participants providing informed consent to the reporting of genomic results to the physician.
Time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
Number of Participants With Actionable Genomic Results
Number of participants with actionable genomic results (defined as having the potential to impact on management recommendations based on diagnostic, prognostic and/or predictive implications), expressed as a percentage of the total number of study participants.
Time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
Number of Participants With Adverse Events Due to Tumor Biopsies on Study
Number of participants with any adverse events possibly, probably or definitely related to tumor biopsies on study; Grading by CTCAE version 4 of adverse events.
Time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
Patient and Physician Experience
Qualitative and quantitative responses on questionnaires and personal interviews regarding patient and physician experience of this research process and their understanding of genomic analysis including perceptions of benefit versus disadvantages, impact on clinical care and decision making
Time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.