Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Solid Tumors
- Sponsor
- University Health Network, Toronto
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years.
- •Histological or cytological proof of solid tumour cancer.
- •At least one biopsiable lesion deemed medically accessible and safe to biopsy.
- •Candidate for one or more phase I or II clinical trials in the local institution or in another Ontario institution, at the time of study enrollment or at a later time point.
- •Fulfills local institution's laboratory parameters for tumor biopsy.
- •Willingness and ability of patient to provide signed voluntary informed consent.
Exclusion Criteria
- •Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
- •Any contraindication to undergoing a biopsy procedure.
Outcomes
Primary Outcomes
Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients
Time Frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
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.
Secondary Outcomes
- Number of Participants With Actionable Genomic Results(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(All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.)
- Patient and Physician Experience(All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.)