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NCT Number: NCT03114618

A New Clinic-Genetic Risk Score for Predicting Venous Thromboembolic Events in Cancer Patient

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.

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Key information

Conditions

Cancer-associated Thrombosis Cardiovascular Diseases Disease Attributes Disease Susceptibility Embolism and Thrombosis Genetic Predisposition Genetic Predisposition to Disease Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Torrecárdenas, Almería, Spain

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About this study

The working hypothesis of this study establishes that the risk of cancer patients suffering a thromboembolic event is conditioned by individual genomic factors. The genes to be analyzed have clearly demonstrated their relationship with thromboembolic disease in other clinical contexts. This study is considered the initiation of a field of research in genomic risk markers indicating a risk of thrombosis in cancer patients. The ultimate goal of the study is to establish a clinic-genomic score for selecting patients with a high risk of suffering thrombotic events who can benefit from guided thromboprophylaxis. Its secondary goal is to prevent the adverse effects of ineffective therapies in other patients (low-risk patients not requiring an anti-thrombotic prophylaxis).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age.
  • 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

  • Life expectancy of less than 3 months.
  • Patients undergoing anti-coagulant treatment before the cancer diagnosis for reasons other than a concurrent venous thromboembolic event.

Treatment and study plan

Primary outcomes

  1. Venous thromboembolism events

    Time frame: During the 18 months of follow up

    The development of venous thromboembolism will be registered

Sponsors and collaborators

Lead sponsor

Andres muñoz

Other

Collaborators

  • Complejo Hospitalario Universitario de Vigo
  • Complejo Universitario Torrecárdenas, Almería
  • Complexo Hospitalario de Ourense
  • Ferrer inCode, S.L.
  • Gendiag
  • Hospital Clinic of Barcelona
  • Hospital General Universitario Elche
  • Hospital General de Ciudad Real
  • Hospital Obispo Polanco
  • Hospital Universitario La Paz
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario de Fuenlabrada
  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
  • LEO Pharma
  • Servicio de Oncología Médica. HGU Gregorio Marañón. Madrid
  • Sociedad Española de Oncología Médica (SEOM)
  • Sociedad Española de Trombosis y Hemostasia (SETH)
  • Unitat d'Hemostasia i Trombosi. Hospital de la Santa Creu i Sant Pau
  • Unitat de Genòmica de Malalties Complexes. Institut d'Investigació Sant Pau
  • University Hospital Virgen de las Nieves

Registry information

Official study title

Genomic Predictors Indicating the Risk of Venous Thromboembolic Disease in Cancer Patients Treated in Outpatient Clinics

Acronym: ONCOTHROMB

Important dates

Study start
2013
Primary completion
2020
Study completion
2021
First posted
Apr 14, 2017
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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