A New Clinic-Genetic Risk Score for Predicting Venous Thromboembolic Events in Cancer Patient
NCT ID: NCT03114618
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
416 participants
OBSERVATIONAL
2013-03-31
2021-02-28
Brief Summary
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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.
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Detailed Description
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The aim is to demonstrate the link between the clinic-genetic profile and the risk of suffering thromboembolic events in the group of cancer patients. The working hypothesis establishes that cancer patients who develop thrombotic events will have a higher score for the thrombosis risk clinic-genetic profile than cancer patients not developing thromboembolic events. The second aim is to analyze whether the thrombosis clinic-genetic risk score improves the detection of patients at risk of suffering a thromboembolic event compared to the Khorana predictive model routinely used (Khorana score).
Current validations ongoing:
An external retrospective validation adding 250 patients more and including D-dimer and other types of high-risk neoplasm.
An external prospective validation (second ONCOTRHROMB12-01 cohort 2) adding 450 patients more and including D-dimer and other types of high-risk neoplasm.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients treated in outpatient clinics with a documented histological or cytological diagnosis for non-microcytic lung, colorectal, biliary tract cancer, pancreatic or esophago-gastric cancer at an advanced stage, locally advanced or localized not previously treated with systemic chemotherapy and/or radiation therapy who are candidate for chemotherapy in outpatient setting.
* Performance status 0-2.
* Patients signing the study informed consent form.
Exclusion Criteria
* Patients undergoing anti-coagulant treatment before the cancer diagnosis for reasons other than a concurrent venous thromboembolic event.
18 Years
99 Years
ALL
No
Sponsors
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Servicio de Oncología Médica. HGU Gregorio Marañón. Madrid
UNKNOWN
Unitat de Genòmica de Malalties Complexes. Institut d'Investigació Sant Pau
UNKNOWN
Hospital Universitario La Paz
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Clinic of Barcelona
OTHER
Hospital Universitario de Fuenlabrada
OTHER
Hospital Universitario Marqués de Valdecilla
OTHER
Complexo Hospitalario de Ourense
OTHER
Complejo Universitario Torrecárdenas, Almería
UNKNOWN
Gendiag
INDUSTRY
Ferrer inCode, S.L.
INDUSTRY
Unitat d'Hemostasia i Trombosi. Hospital de la Santa Creu i Sant Pau
UNKNOWN
LEO Pharma
INDUSTRY
Sociedad Española de Trombosis y Hemostasia (SETH)
UNKNOWN
Sociedad Española de Oncología Médica (SEOM)
UNKNOWN
University Hospital Virgen de las Nieves
OTHER
Hospital Obispo Polanco, Teruel
UNKNOWN
Complejo Hospitalario Universitario de Vigo
OTHER
Hospital General Universitario Elche
OTHER
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Hospital General de Ciudad Real
OTHER
Andres muñoz
OTHER
Responsible Party
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Andres muñoz
MD PhD
Principal Investigators
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Andrés J. Muñoz Martín, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañón
Locations
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Complejo Hospitalario Torrecárdenas
Almería, Almería, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Clinic
Barcelona, , Spain
Hospital Virgen de las Nieves
Granada, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario la Paz
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Complejo Hospitalario de Orense
Ourense, , Spain
Countries
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References
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Soria JM, Morange PE, Vila J, Souto JC, Moyano M, Tregouet DA, Mateo J, Saut N, Salas E, Elosua R. Multilocus genetic risk scores for venous thromboembolism risk assessment. J Am Heart Assoc. 2014 Oct 23;3(5):e001060. doi: 10.1161/JAHA.114.001060.
Rubio-Terres C, Soria JM, Morange PE, Souto JC, Suchon P, Mateo J, Saut N, Rubio-Rodriguez D, Sala J, Gracia A, Pich S, Salas E. Economic analysis of thrombo inCode, a clinical-genetic function for assessing the risk of venous thromboembolism. Appl Health Econ Health Policy. 2015 Apr;13(2):233-42. doi: 10.1007/s40258-015-0153-x.
Munoz Martin AJ, Ortega I, Font C, Pachon V, Castellon V, Martinez-Marin V, Salgado M, Martinez E, Calzas J, Ruperez A, Souto JC, Martin M, Salas E, Soria JM. Multivariable clinical-genetic risk model for predicting venous thromboembolic events in patients with cancer. Br J Cancer. 2018 Apr;118(8):1056-1061. doi: 10.1038/s41416-018-0027-8. Epub 2018 Mar 28.
Munoz A, Ay C, Grilz E, Lopez S, Font C, Pachon V, Castellon V, Martinez-Marin V, Salgado M, Martinez E, Calzas J, Ortega L, Ruperez A, Salas E, Pabinger I, Soria JM. A Clinical-Genetic Risk Score for Predicting Cancer-Associated Venous Thromboembolism: A Development and Validation Study Involving Two Independent Prospective Cohorts. J Clin Oncol. 2023 Jun 1;41(16):2911-2925. doi: 10.1200/JCO.22.00255. Epub 2023 Feb 2.
Other Identifiers
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ONCOTHROMB12-01
Identifier Type: -
Identifier Source: org_study_id
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