An interventional study of Genetic Counselling and Testing in Pancreatic Cancer, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Health services research
Pancreatic cancer (PC) has a dismal prognosis. Approximately 10% of PC patients carry a germline pathogenic variant in a cancer susceptibility gene, whose identification can lead to better treatments for the patient and participation in cancer prevention programs for their family members. Conventional genetic testing for PC patients is based on the family history of cancer, and may take up to six months from the point of meeting with the treating physician to receiving the results from a genetic counsellor. The median overall survival for these patients is 6 - 12 months, which may prevent them from having the genetic testing in the first place, or from receiving further targeted treatments. Patients with PC need a more comprehensive knowledge of their disease for better treatment planning. This includes genetic testing in absence of family history of cancer.
The investigators designed a one year study to assess the feasibility of medical oncologist initiated cancer genetic testing for all newly diagnosed PC patients unselected by family history.
For patients with negative genetic testing, no further testing will be ordered after the disclosure of results. Patients with positive genetic testing results will be informed and referred to Cancer Genetics Clinic. The investigators expect to enroll 100 patients in 1 year. Patients will be asked to complete satisfaction questionnaires according to the Satisfaction with Genetic Counseling Scale in multiple time points (pre-testing, post-testing, at 6 months and at 12 months). Designated oncologists will be asked to evaluate the process using the Oncologist Satisfaction Survey after every five counseled patients.
Three primary objectives will include 1) assessment of the turnaround time for genetic testing results; 2) assessment of patient satisfaction; 3) assessment of oncologist's satisfaction. Secondary objectives will include assessment of association between genetic testing results and types of treatment and overall survival.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 100 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed exocrine pancreatic cancer
Exclusion Criteria:
All subjects receive Oncologist Led Genetic Counselling and Testing
Procedure: Genetic Counselling and Testing
Oncologist-initiated brief genetic counselling and testing
Days from decision to test to receiving genetic test results
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre