Feasibility Clinical Study of Targeted and Genome-Wide Sequencing
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|ClinicalTrials.gov Identifier: NCT01345513|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2011
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment|
|Solid Tumors||Other: Sample Collection for Genome-Wide Sequencing|
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|Official Title:||Feasibility Clinical Study of Targeted and Genome-Wide Sequencing|
|Actual Study Start Date :||March 2011|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||June 2018|
|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)
- 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. ]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. ]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. ]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. ]Qualitative and quantitative responses on questionnaires and personal interviews.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345513
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Lillian Siu, MD||Princess Margaret Hospital, Canada|