Clinical Trials Directory

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UnknownNCT04316507

Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Sunnybrook Health Sciences Centre · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREGenetic Counselling and TestingOncologist-initiated brief genetic counselling and testing

Timeline

Start date
2020-04-01
Primary completion
2021-03-31
Completion
2021-03-31
First posted
2020-03-20
Last updated
2020-10-23

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04316507. Inclusion in this directory is not an endorsement.