Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pancreatic-cancer
Started Apr 2020
Shorter than P25 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 20, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedOctober 23, 2020
October 1, 2020
12 months
March 10, 2020
October 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Days from decision to test to receiving genetic test results
1 year
Study Arms (1)
Oncologist led genetic counselling and testing
EXPERIMENTALAll subjects receive Oncologist Led Genetic Counselling and Testing
Interventions
Oncologist-initiated brief genetic counselling and testing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient declines genetic testing
- Blood transfusion within the past month
- Allogenic bone marrow transplantation
- History of comprehensive panel genetic testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4n 3M5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2020
First Posted
March 20, 2020
Study Start
April 1, 2020
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
October 23, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share