NCT03114618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

7.8 years

First QC Date

March 14, 2017

Last Update Submit

April 7, 2022

Conditions

Cancer-associated ThrombosisGenetic Predisposition

Keywords

Venous thrombosisCancerRisk Model AssessmentGenomic

Outcome Measures

Primary Outcomes (1)

  • Venous thromboembolism events

    The development of venous thromboembolism will be registered

    During the 18 months of follow up

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include patients diagnosed with colorectal, esophago-gastric, biliary tract, pancreas or lung cancer who have not previously been treated with chemotherapy or chemotherapy and radiation therapy and are candidate for chemotherapy in outpatient setting

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Complejo Hospitalario Torrecárdenas

Almería, Almería, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital Virgen de las Nieves

Granada, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario la Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Complejo Hospitalario de Orense

Ourense, Spain

Location

Related Publications (4)

  • 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.

    PMID: 25341889RESULT

  • 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.

    PMID: 25652150RESULT

  • 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.

    PMID: 29588512RESULT

  • 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.

    PMID: 36730884DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA Blood sample

MeSH Terms

Conditions

Genetic Predisposition to DiseaseVenous ThrombosisNeoplasms

Condition Hierarchy (Ancestors)

Disease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Andrés J. Muñoz Martín, MD PhD

    Hospital General Universitario Gregorio Marañón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 14, 2017

First Posted

April 14, 2017

Study Start

March 1, 2013

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

ES(9)