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Cancer-related Thromboembolic Disease

NCT02785757 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-01-06

No results posted yet for this study

Summary

Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.

The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk

The secondary objectives are:

* To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
* To evaluate values of other clotting activation markers in patients with cancer

Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.

Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.

The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.

Conditions

  • Adenocarcinoma

Interventions

OTHER

Thrombin Generation Assay

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-12
Primary Completion
2024-02-12
Completion
2024-02-12

Countries

  • France

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 NCT02785757 on ClinicalTrials.gov