Cancer-related Thromboembolic Disease (PROSPECT)

January 5, 2021 updated by: Hospices Civils de Lyon

The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France, 69500
        • Recruiting
        • Unité d'Hémostase Clinique Hôpital Louis Pradel
        • Contact:
        • Principal Investigator:
          • Yesim Dargaud, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with adenocarcinoma
60 Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
Other: Thrombin Generation Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
thrombin generation assay results
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clotting activation markers: thrombin-antithrombin complexes (TAT)
Time Frame: 7 months
7 months
Clotting activation markers: prothrombin fragment F1+2
Time Frame: 7 months
7 months
Clotting activation markers: D-dimer
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2014

Primary Completion (Anticipated)

February 12, 2024

Study Completion (Anticipated)

February 12, 2024

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.788
  • 2013-A00065-40 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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