Overview

This trial is active, not recruiting.

Condition solid tumors
Treatment sample collection for genome-wide sequencing
Phase phase 1
Sponsor University Health Network, Toronto
Start date March 2011
End date January 2017
Trial size 45 participants
Trial identifier NCT01345513, TGWS-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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)

Primary Outcomes

Measure
Time from patient recruitment to final results ≤ 3 weeks 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.

Secondary Outcomes

Measure
Number of participants with actionable genomic results
time frame: 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
time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
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
time frame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
Principal investigator Lillian Siu, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.