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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03114618
Acronym
ONCOTHROMB
Enrollment
416
Registered
2017-04-14
Start date
2013-03-31
Completion date
2021-02-28
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-associated Thrombosis, Genetic Predisposition

Keywords

Venous thrombosis, Cancer, Risk Model Assessment, Genomic

Brief 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.

Detailed description

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Venous thromboembolism eventsDuring the 18 months of follow upThe development of venous thromboembolism will be registered

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026