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Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

Phase 1
18 Years
Not Enrolling
Solid Tumors

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Trial Information

Feasibility Clinical Study of Targeted and Genome-Wide Sequencing

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.

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

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time from patient recruitment to final results ≤ 3 weeks in ≥ 90% of patients

Outcome Description:

Average and range of time (in weeks) that occur between study participants providing informed consent to the reporting of genomic results to the physician.

Outcome Time Frame:

All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.

Safety Issue:


Principal Investigator

Lillian Siu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Ethics Review Committee

Study ID:




Start Date:

March 2011

Completion Date:

June 2013

Related Keywords:

  • Solid Tumors
  • Genomic Analysis
  • Sequencing
  • Genetic
  • Biopsy
  • Solid tumors