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

Titre officiel

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

Sommaire:

Il existe un large éventail d’outils pronostiques et prédictifs pour les patientes ayant reçu un diagnostic récent de cancer du sein à un stade précoce. Ces outils vont des algorithmes mathématiques gratuits et accessibles au grand public aux tests génomiques coûteux. On ne connaît pas l’incidence de l’utilisation de ces différents scores sur la prise de décisions des médecins en ce qui concerne la demande de tests génomiques, et on ignore dans quelle mesure ces algorithmes prédisent les résultats du test Oncotype DX® en situation réelle. Cette étude pragmatique permettra de découvrir des éléments de réponse à ces questions.

Description de l'essai

Primary Outcome:

• Rate of requests for Oncotype DX testing

Secondary Outcome:

• Routine availability of PREDICT 2.1
• Oncotype DX ® cost
• Physician survey

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.

Voir cet essai sur ClinicalTrials.gov