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NCT05806632: ARIAS
Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification
trial testing Prognostic model in Local Cancer in 108 participants. Status unknown.
22 December 2022
Quick facts
| Lead sponsor | Regina Elena Cancer Institute |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 108 |
| Start date | 21 January 2020 |
| Primary completion | 22 December 2022 |
| Estimated completion | 31 December 2023 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- Prognostic model
Conditions studied
- Local Cancer — all drugs for Local Cancer →
Sponsor
Regina Elena Cancer Institute
Who can join
18 and older, any sex, with Local Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05806632
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05806632 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Regina Elena Cancer Institute
- Last refreshed: 10 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05806632.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing