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Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients

Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04316507
Enrollment
100
Registered
2020-03-20
Start date
2020-04-01
Completion date
2021-03-31
Last updated
2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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.

Interventions

PROCEDUREGenetic Counselling and Testing

Oncologist-initiated brief genetic counselling and testing

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Days from decision to test to receiving genetic test results1 year

Countries

Canada

Contacts

Primary ContactAndrea Eisen, MD
andrea.eisen@sunnybrook.ca416 4804617
Backup ContactNeda Stjepanovic, MD
neda.stjepanovic@sunnybrook.ca416 480 4617

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026