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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03114618 on ClinicalTrials.gov