Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01345513
First received: April 21, 2011
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Other: Sample Collection for Genome-Wide Sequencing
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Average and range of time (in weeks) that occur between study participants providing informed consent to the reporting of genomic results to the physician.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    Qualitative and quantitative responses on questionnaires and personal interviews.


Biospecimen Retention:   Samples With DNA

Archival tumor tissue, fresh tumor biopsy, blood sample, pleural effusion (if available)or ascites (if available)


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients from the Princess Margaret Hospital or other Ontario Institution

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345513

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Lillian Siu, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01345513     History of Changes
Other Study ID Numbers: TGWS-001
Study First Received: April 21, 2011
Last Updated: January 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Genomic Analysis
Sequencing
Genetic
Biopsy
Solid tumors

ClinicalTrials.gov processed this record on April 23, 2014