Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer (REaCT-Algorith)
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|ClinicalTrials.gov Identifier: NCT04131933|
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : May 27, 2020
|Condition or disease|
A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage hormone receptor positive, Her2 negative breast cancer. These range from free and publicly available mathematical algorithms (e.g. NHS Predict, Magee formulae, Gage and Tennessee equations) that incorporate standard pathology results, through to expensive genomic tests (e.g. Oncotype DX ® and Endopredict ®). It is not known how the use of these different scores affects physician decision making with respect to ordering genomic tests, nor how well these algorithms predict for the results of Oncotype DX ® in the real-world setting. This pragmatic study will help to answer these questions.
In summary: Month 1 to 3: pathology and chemotherapy data is collected, no physician questionnaires given. Month 4 to 6: pathology and chemotherapy data collected, plus physician questionnaire administered. Intervention teaching after 6 months of study activation. Month 7 to 9: pathology and chemotherapy data collected, PREDICT 2.1 tool used, no physician questionnaire given. Month 10 to 12: pathology and chemotherapy data collected, PREDICT 2.1 tool used, plus physician questionnaire administered.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||A Multi-centre, Prospective, Observational Study Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer|
|Actual Study Start Date :||March 6, 2020|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||August 2021|
- Rate of requests for Oncotype DX testing [ Time Frame: 12 Months ]To assess whether providing individual patient prognostic and predictive scores from PREDICT 2.1 affects the rate of subsequent requests for Oncotype DX ® testing. This will be the proportion of patients for which Oncotype DX ® is ordered, defined as the number of patients with Oncotype DX ® ordered divided by the number of patients eligible for Oncotype DX ® testing.
- Routine availability of PREDICT 2.1 [ Time Frame: 12 Months ]To assess whether routine availability of PREDICT 2.1 affects adjuvant treatment (chemotherapy, radiation therapy and endocrine therapy). This will be done by identifying the time to starting chemotherapy, endocrine therapy or radiation therapy.
- Oncotype DX ® cost [ Time Frame: 12 Months ]Prognostic risk scores, including Magee formulae, Gage and Tennessee equations will be calculated using patient and tumour characteristics. These scores will be compared with Oncotype DX ® scores when performed. These will be used to determine Oncotype DX ® cost and total health system costs and subsequent health care utilization.
- Physician survey [ Time Frame: 3 months and 9 months ]A physician survey will be used to assess physician comfort when making systemic therapy decisions.It will determine whether the routine availability of PREDICT 2.1 score in the clinic enhanced their comfort with systemic therapy decision-making.
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): NCT04131933
|Contact: Lisa Vandermeer||613-737-7700 ext email@example.com|
|Contact: Deanna Saunders||613-737-7700 ext firstname.lastname@example.org|
|Ottawa Hospital Research Institute||Recruiting|
|Ottawa, Ontario, Canada|
|Contact: Lisa Vandermeer 613-737-7700 ext 73039 email@example.com|
|Principal Investigator:||Arif Awan, MD||Ottawa Hospital Research Institute|