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Trial Title:
Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification
NCT ID:
NCT05806632
Condition:
Local Cancer
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Prognostic model
Description:
Risk assessment and risk stratification
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.
Criteria for eligibility:
Study pop:
Patients with stage IIB-IIIC breast cancer undergoing neoadjuvant chemotherapy (NACT),
followed by breast surgery
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Policlinico Umberto I
Address:
City:
Roma
Zip:
00161
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paolo Marchetti
Facility:
Name:
Policlinico Agostino Gemelli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paola Cassano
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Start date:
January 21, 2020
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05806632
