A New Clinic-Genetic Risk Score for Predicting Venous Thromboembolic Events in Cancer Patient
NCT03114618 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 416
Last updated 2022-04-14
Summary
Venous thromboembolism (VTE) is a common disease in cancer patients and one of the major causes of cancer-associated mortality. Risk for developing VTE increases when cancer patients are receiving chemotherapy. Current risk scores for predicting cancer-associated VTE in ambulatory patients had low/moderate discrimination and clinical sensitivity. These models use clinical and biochemical parameters of the patient.
In the development of VTE genetics play a relevant role. The product Thrombo inCode (TiC) assess VTE risk prediction by using a combination of a genetic risk score (GRS) and clinical parameters from the patient. The investigators hypothesized that the GRS included in TiC combined with clinical parameter some of them associated with cancer could be better predicted by TiC than by current risk scores (Khorana score).
After publishing the primary results in 2018, we have expanded the GRS in a external validation cohort adding gliomas and biliary tract tumors. Also we have incorporated the assessment of D-dimer in order to improve the predictive capability.
Conditions
- Cancer-associated Thrombosis
- Genetic Predisposition
Sponsors & Collaborators
-
Servicio de Oncología Médica. HGU Gregorio Marañón. Madrid
collaborator UNKNOWN -
Unitat de Genòmica de Malalties Complexes. Institut d'Investigació Sant Pau
collaborator UNKNOWN -
Hospital Universitario La Paz
collaborator OTHER -
Hospital Universitario Ramon y Cajal
collaborator OTHER -
Hospital Clinic of Barcelona
collaborator OTHER -
Hospital Universitario de Fuenlabrada
collaborator OTHER -
Hospital Universitario Marqués de Valdecilla
collaborator OTHER -
Complexo Hospitalario de Ourense
collaborator OTHER -
Complejo Universitario Torrecárdenas, Almería
collaborator UNKNOWN -
Gendiag
collaborator INDUSTRY -
Ferrer inCode, S.L.
collaborator INDUSTRY -
Unitat d'Hemostasia i Trombosi. Hospital de la Santa Creu i Sant Pau
collaborator UNKNOWN -
LEO Pharma
collaborator INDUSTRY -
Sociedad Española de Trombosis y Hemostasia (SETH)
collaborator UNKNOWN -
Sociedad Española de Oncología Médica (SEOM)
collaborator UNKNOWN -
University Hospital Virgen de las Nieves
collaborator OTHER -
Hospital Obispo Polanco, Teruel
collaborator UNKNOWN -
Complejo Hospitalario Universitario de Vigo
collaborator OTHER -
Hospital General Universitario Elche
collaborator OTHER -
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
collaborator OTHER -
Hospital General de Ciudad Real
collaborator OTHER -
Andres muñoz
lead OTHER
Principal Investigators
-
Andrés J. Muñoz Martín, MD PhD · Hospital General Universitario Gregorio Marañón
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2020-12-31
- Completion
- 2021-02-28
Countries
- Spain
Study Locations
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