Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

Solid Tumors Clinical Trial

Official title:

Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345513
• Other study ID #: TGWS-001
• Status: Completed
• Start date: March 2011
• Est. completion date: January 21, 2019

Study information

• Verified date: March 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 21, 2019
• Est. primary completion date: March 25, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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)

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.