Clinical trial NCT02785757: Cancer-related Thromboembolic Disease
Official title: The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenocarcinoma
Keywords: adenocarcinoma
venous thromboembolism
thrombin generation assay
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients of both sexes with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
* Subjects having signed Informed Consent prior to initiation of any study procedure
* Covered by a Health System

Exclusion Criteria:

* Known bleeding or thrombophilia disorders
* Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
* Patient immobilized
* Confirmed venous thromboembolism in the last 12 months
* Active bleeding or bleedings in the last 4 weeks requiring hospitalization, transfusion, or surgical intervention
* Anticoagulant therapy at the moment of first sampling (at least one day off for Heparines and DOAc; at least 5 days off for VKA is needed)
* Antiplatelet therapy at the moment of first sampling (only if PRP TGA can be performed at site)
* Severe hepatic insufficiency
* Life expectancy of less than 3 months
* Pregnancy

Primary outcomes:
measure: thrombin generation assay results
timeFrame: 7 months
Secondary outcomes:
measure: Clotting activation markers: thrombin-antithrombin complexes (TAT)
timeFrame: 7 months
measure: Clotting activation markers: prothrombin fragment F1+2
timeFrame: 7 months
measure: Clotting activation markers: D-dimer
timeFrame: 7 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Unité d'Hémostase Clinique Hôpital Louis Pradel
Study officials:
References: