Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients
Primary Purpose
Pancreatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Genetic Counselling and Testing
Sponsored by
About this trial
This is an interventional health services research trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
• Newly diagnosed exocrine pancreatic cancer
- Patient consents to blood draw and genetic testing
- Treating oncologist at Odette Cancer Centre
- No conditions that would prevent patients from completing the study-related questionnaires or understanding the consent process
- Valid phone number
- Email address to send link to online family history questionnaire
- Treating physician agrees to complete the referrals
Exclusion Criteria:
- Patient declines genetic testing
- Blood transfusion within the past month
- Allogenic bone marrow transplantation
- History of comprehensive panel genetic testing
Sites / Locations
- Sunnybrook Odette Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oncologist led genetic counselling and testing
Arm Description
All subjects receive Oncologist Led Genetic Counselling and Testing
Outcomes
Primary Outcome Measures
Days from decision to test to receiving genetic test results
Secondary Outcome Measures
Full Information
NCT ID
NCT04316507
First Posted
March 10, 2020
Last Updated
October 21, 2020
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT04316507
Brief Title
Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients
Official Title
Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oncologist led genetic counselling and testing
Arm Type
Experimental
Arm Description
All subjects receive Oncologist Led Genetic Counselling and Testing
Intervention Type
Procedure
Intervention Name(s)
Genetic Counselling and Testing
Intervention Description
Oncologist-initiated brief genetic counselling and testing
Primary Outcome Measure Information:
Title
Days from decision to test to receiving genetic test results
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Newly diagnosed exocrine pancreatic cancer
Patient consents to blood draw and genetic testing
Treating oncologist at Odette Cancer Centre
No conditions that would prevent patients from completing the study-related questionnaires or understanding the consent process
Valid phone number
Email address to send link to online family history questionnaire
Treating physician agrees to complete the referrals
Exclusion Criteria:
Patient declines genetic testing
Blood transfusion within the past month
Allogenic bone marrow transplantation
History of comprehensive panel genetic testing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Eisen, MD
Phone
416 4804617
Email
andrea.eisen@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Neda Stjepanovic, MD
Phone
416 480 4617
Email
neda.stjepanovic@sunnybrook.ca
Facility Information:
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4n 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neda Stjepanovic, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients
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