Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Local Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prognostic model | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathological response rate
- timeFrame
- 30 months
- description
- The study will mainly aim to validate the accuracy of previous developed prognostic model in distinguish between risk categories and probabilities of pathological complete response (pCR) detected in patients undergoing neoadjuvant chemotherapy (NACT) and breast surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with normal organ functions * Cytologically/histologically proven breast cancer, stage IIB-IIIC * Participants must not have prophylactic or therapeutic indications for anticoagulants. Exclusion Criteria: * Pregnacy * Metastatic breast cancer * Previous chemotherapy, hormone therapy, radiotherapy * Previous malignancies or contralateral breast cancer
References
Publications (0)
Data not yet available