Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-21

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Local Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Prognostic model

Risk assessment and risk stratification

Intervention Type OTHER

Eligibility Criteria

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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.