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Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients

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ClinicalTrials.gov Identifier: NCT04316507
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Genetic Counselling and Testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021


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




Primary Outcome Measures :
  1. Days from decision to test to receiving genetic test results [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316507


Contacts
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Contact: Andrea Eisen, MD 416 4804617 andrea.eisen@sunnybrook.ca
Contact: Neda Stjepanovic, MD 416 480 4617 neda.stjepanovic@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4n 3M5
Contact: Neda Stjepanovic, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04316507    
Other Study ID Numbers: 437-2019
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases