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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
History of Changes

April 21, 2011
January 14, 2013
March 2011
June 2013   (final data collection date for primary outcome 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. ] [ 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.
Same as current
Complete list of historical versions of study NCT01345513 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Patients from the Princess Margaret Hospital or other Ontario Institution
Solid Tumors
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)
Solid Tumor Cancer
Intervention: Other: Sample Collection for Genome-Wide Sequencing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
150
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01345513
TGWS-001
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Lillian Siu, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP