NCT05806632

Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification

Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification in Reference to Patient Important Outcomes for Locally Advanced Breast Cancer: The ARIAS Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 108 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Carcinogenesis and coagulation activation are closely related processes. In a previous study of coagulation activation in stage I-IIA breast cancer patients, we developed a prognostic model that includes coagulation activation biomarkers and demonstrated efficacy to in distinguish between risk categories and survival. Here, we propose a study useful for the validation of this prognostic model in an independent cohort of 108 patients with locally advanced breast cancer and indicated for neoadjuvant chemotherapy, followed by breast surgery. Within this study population, we will validate our prognostic model for risk assessment and risk stratification with respect to the following endpoints: 1. Complete pathological response rate to definitive breast surgery; 2. Rate of thromboembolic events.

Conditions

• Local Cancer

Interventions

Type	Name	Description
OTHER	Prognostic model	Risk assessment and risk stratification

Timeline

• Start date: 2020-01-21
• Primary completion: 2022-12-22
• Completion: 2023-12-31
• First posted: 2023-04-10
• Last updated: 2023-04-10

Locations

3 sites across 1 country: Italy