Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
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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 |
- 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.
- 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.
Biospecimen Retention: Samples With DNA
Archival tumor tissue, fresh tumor biopsy, blood sample, pleural effusion (if available)or ascites (if available)
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients from the Princess Margaret Hospital or other Ontario Institution
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| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: | Lillian Siu, MD | Princess Margaret Hospital, Canada |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01345513 History of Changes |
| Other Study ID Numbers: | TGWS-001 |
| Study First Received: | April 21, 2011 |
| Last Updated: | January 14, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University Health Network, Toronto:
|
Genomic Analysis Sequencing Genetic Biopsy Solid tumors |
ClinicalTrials.gov processed this record on May 21, 2013