Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Other: Sample Collection for Genome-Wide Sequencing

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients from the Princess Margaret Hospital or other Ontario Institution

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Solid Tumor Cancer	Other: Sample Collection for Genome-Wide Sequencing; Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): March 25, 2013
• Study Completion (Actual): January 21, 2019

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Genetic; Solid tumors; Biopsy; Sequencing; Genomic Analysis
• Other Study ID Numbers: TGWS-001