Cancer-related Thromboembolic Disease

NCT ID: NCT02785757

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-12
• Study Completion Date: 2024-02-12

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.

Conditions

Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with adenocarcinoma

60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy

Group Type: EXPERIMENTAL

Thrombin Generation Assay

Intervention Type: OTHER

Interventions

Thrombin Generation Assay

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Unité d'Hémostase Clinique Hôpital Louis Pradel

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Yesim DARGAUD, MD PHD

Role: CONTACT

ydargaud@univ-lyon1.fr

(0)4 72 11 88 25 ext. +33

Facility Contacts

Yesim Dargaud, MD, PhD

Role: primary

ydargaud@univ-lyon1.fr

(0)4 72 11 88 25 ext. +33

Other Identifiers

2013-A00065-40

Identifier Type: OTHER

Identifier Source: secondary_id

2012.788

Identifier Type: -

Identifier Source: org_study_id