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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prognostic model | Other | Risk assessment and risk stratification |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response rate | 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. | 30 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage IIB-IIIC breast cancer undergoing neoadjuvant chemotherapy (NACT), followed by breast surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrizia Vici, MD | Contact | +39 06 52665698 | patrizia.vici@ifo.gov.it | |
| Maddalena Barba, MD | Contact | +39 0652665419 | maddalena.barba@ifo.gov.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Umberto I | Recruiting | Roma | 00161 | Italy |
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| Policlinico Agostino Gemelli | Recruiting | Roma | 00168 | Italy |
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| "Regina Elena" National Cancer Institute | Recruiting | Rome | 00144 | Italy |