ARIAS: Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification

Sponsor
Regina Elena Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05806632
Collaborator
(none)
108
3
47.3
36
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Prognostic model

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
108 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification in Reference to Patient Important Outcomes for Locally Advanced Breast Cancer: The ARIAS Trial
Actual Study Start Date :
Jan 21, 2020
Actual Primary Completion Date :
Dec 22, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Policlinico Umberto I Roma Italy 00161
2 Policlinico Agostino Gemelli Roma Italy 00168
3 "Regina Elena" National Cancer Institute Rome Italy 00144

Sponsors and Collaborators

  • Regina Elena Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT05806632
Other Study ID Numbers:
  • RS1307/20
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 10, 2023