Clinical trial NCT01345513: Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
Official title: Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumors
Keywords: Genomic Analysis
Sequencing
Genetic
Biopsy
Solid tumors
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from the Princess Margaret Hospital or other Ontario Institution

Brief summary: 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.

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 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.

Primary outcomes:
measure: Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients
timeFrame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
Secondary outcomes:
measure: Number of Participants With Actionable Genomic Results
timeFrame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
measure: Number of Participants With Adverse Events Due to Tumor Biopsies on Study
timeFrame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
measure: Patient and Physician Experience
timeFrame: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Lillian Siu, MD
role: PRINCIPAL_INVESTIGATOR
References: