Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT04131933
Brief Summary:
A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage breast cancer. These range from free and publicly available mathematical algorithms, through to expensive genomic tests. 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.
Detailed Description:
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:
NCT04131933
Study Brief:
Protocol Section:
NCT04131933