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Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345513
First Posted: May 2, 2011
Last Update Posted: June 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Health Network, Toronto
  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

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. ]
    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. ]
    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. ]
    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. ]
    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: 45
Study Start Date: March 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: January 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01345513     History of Changes
Other Study ID Numbers: TGWS-001
First Submitted: April 21, 2011
First Posted: May 2, 2011
Last Update Posted: June 22, 2016
Last Verified: June 2016

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