Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients
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|ClinicalTrials.gov Identifier: NCT04316507|
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : October 23, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Procedure: Genetic Counselling and Testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
Experimental: Oncologist led genetic counselling and testing
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 ]
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): NCT04316507
|Contact: Andrea Eisen, MD||416 firstname.lastname@example.org|
|Contact: Neda Stjepanovic, MD||416 480 email@example.com|
|Sunnybrook Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4n 3M5|
|Contact: Neda Stjepanovic, MD|