Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification

Recruiting

• Conditions: Local Cancer

• Registration Number: NCT05806632
• Lead Sponsor: Regina Elena Cancer Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-21
• Primary Completion: 2022-12-22
• Status Verified: 2023-03
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Study First Posted: 2023-04-10
• Last Update Posted: 2023-04-10
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological response rate	30 months	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.

Trial Locations

Locations (3)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy

Policlinico Umberto I; 🇮🇹 Roma, Italy

Policlinico Agostino Gemelli; 🇮🇹 Roma, Italy