跳至主要内容
临床试验/NCT04316507
NCT04316507Unknown不适用

Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Days from decision to test to receiving genetic test results

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 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

排除标准

  • Patient declines genetic testing
  • Blood transfusion within the past month
  • Allogenic bone marrow transplantation
  • History of comprehensive panel genetic testing

结局指标

主要结局

Days from decision to test to receiving genetic test results

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验