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Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification

NCT05806632 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2023-04-10

No results posted yet for this study

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

OTHER

Prognostic model

Risk assessment and risk stratification

Sponsors & Collaborators

  • Regina Elena Cancer Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2022-12-22
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806632 on ClinicalTrials.gov