Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

Conditions
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Solid Tumors

Intervention / Treatment
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* Other: Sample Collection for Genome-Wide Sequencing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Solid Tumor Cancer<br> | Other: Sample Collection for Genome-Wide Sequencing<br>* Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genomic Analysis, Sequencing, Genetic, Biopsy, Solid tumors