Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Procedure: Genetic Counselling and Testing

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Eisen, MD; Phone Number: 416 4804617; Email: andrea.eisen@sunnybrook.ca
• Study Contact Backup: Name: Neda Stjepanovic, MD; Phone Number: 416 480 4617; Email: neda.stjepanovic@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Odette Cancer Centre
      • Contact: Neda Stjepanovic, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Days from decision to test to receiving genetic test results	1 year

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 437-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No