Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

Sponsors

Lead Sponsor: University Health Network, Toronto

Source University Health Network, Toronto
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.

Overall Status Completed
Start Date March 2011
Completion Date January 21, 2019
Primary Completion Date March 25, 2013
Study Type Observational
Primary Outcome
Measure Time Frame
Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
Secondary Outcome
Measure Time Frame
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.
Enrollment 50
Condition
Intervention

Intervention Type: Other

Intervention Name: Sample Collection for Genome-Wide Sequencing

Description: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)

Arm Group Label: Solid Tumor Cancer

Eligibility

Sampling Method: Probability Sample

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Lillian Siu, MD Principal Investigator Princess Margaret Hospital, Canada
Location
Facility: Princess Margaret Hospital
Location Countries

Canada

Verification Date

March 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Arm Group

Label: Solid Tumor Cancer

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov