NCT04301362

Brief Summary

The main venous thromboembolism (VTE) risk prediction model for ambulatory cancer patients is Khorana. Cancer thrombosis is associated with elevated thrombin generation. Its quantification is a promising method for evaluating patient's thrombotic profile. This study aims to develop a predictive model of VTE risk in ambulatory cancer patients, combining thrombosis biomarkers (D-dimers and thrombin generation potential) with the Khorana score. This is a prospective observational study that includes newly diagnosed cancer patients proposed for anti-tumor treatment (chemotherapy, immunotherapy or targeted therapies). Patients with disease progression are allowed if chemotherapy-free for 3 months. A 6-month mean incidence of VTE 6-10% is expected, requiring a sample size of 600 patients. Blood sample is collected at inclusion to analyze thrombosis biomarkers and blood count. The primary endpoint is the occurrence of symptomatic or incidental VTE within 6 months of inclusion. Models will follow a logistic approach with K-fold cross-validation (k=10). Model quality will be assessed with Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC). Decision for entering predictors in multivariate models will be based on p \<.10 in the univariate analysis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 19, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2021

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 6, 2020

Last Update Submit

March 10, 2020

Conditions

CancerThromboembolismThrombosisBiomarkers

Keywords

KhoranaThrombin generationVenous thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Occurrence of symptomatic or incidental VTE

    Confirmed by vascular ultrasound, thoracic angiography, and/or ventilation/perfusion scintigraphy. There will be no routine screening for VTE diagnosis. The symptomatic and incidental episodes documented in the clinical process and complementary diagnostic tests will be considered.

    6 months

Secondary Outcomes (3)

  • Mortality

    6 months

  • Risk factors for the development of VTE

    6 months

  • Major Bleeding

    6 months

Interventions

Thrombosis biomarkersDIAGNOSTIC_TEST

Blood samples shall be prepared according to the manufacturer's instructions and stored at -80°C until analysis. Thrombin generation will be measured using the commercial kit STG®-Tromboscreen kit (Stago). The D-dimers will be quantified using STA LIATEST® D-DI PLUS (Stago).

Eligibility Criteria

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

Cancer patients admitted to Medical Oncology, Clinical Hematology, and Pulmonology consultations at Centro Hospitalar Vila Nova de Gaia/Espinho, Portugal.

You may qualify if:

  • Patients older than 18 years.
  • Newly diagnosed cancer patients, proposed for anti-tumor medical treatment (chemotherapy, immunotherapy and targeted therapies).
  • Patients with a cancer diagnosis, previously under medical anti-tumor treatments, with disease progression proposed for a new line of anti-tumor treatment, who have not recently received chemotherapy (within the last three months).
  • Follow-up in Medical Oncology, Clinical Hematology, and Pulmonology consultations at Centro Hospitalar Vila Nova de Gaia/Espinho.

You may not qualify if:

  • Major bleeding in the last 3 months.
  • Major surgery in the last 28 days.
  • Patients on anticoagulation/antithrombotic therapy
  • Pregnant or breastfeeding women.
  • Patients previously submitted to bone marrow transplantation.
  • Inaccessibility to the results of the biomarkers or other elements provided for in the Khorana score.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, 4434-502, Portugal

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

NeoplasmsThromboembolismThrombosisVenous Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • David Ferreira, MD

    Centro Hospitalar Vila Nova de Gaia/Espinho

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferreira

CONTACT

+351933203930dr.davidferreira@gmail.com

Lopes

CONTACT

+351915281937sarapblopes@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Immunohemotherapy Department

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

July 19, 2019

Primary Completion

July 19, 2021

Study Completion

December 19, 2021

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

No applicable

Locations

PT(1)