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Completed

NCT Number: NCT01345513

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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sample Collection for Genome-Wide Sequencing

Other

Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)

Primary outcomes

  1. Time From Patient Recruitment to Final Results ≤ 21 Days 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 calendar days) that occurred between study participants providing informed consent to the reporting of genomic results to the physician.

Secondary outcomes

  1. 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.

  2. 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.

  3. Patient and Physician Experience

    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 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2019
First posted
May 2, 2011
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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