Evaluation of Fibrin Structure Marker in Cancer Patients Treated and Not Treated With LMWH (FICT)

January 6, 2020 updated by: Diagnostica Stago R&D
The purpose of the study is to assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic or therapeutic doses, in order to determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients without treatment and in patients under LMWH treatment will be recorded, depending on the location and type of cancer, metastases, and treatment of cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale. Venous thromboembolism (VTE) is a major complication often encountered in oncology and onco-hematology, and difficult to handle. It involves the activation of coagulation with the generation of fibrin and plasmin and angiogenesis activation. Low molecular weight heparins (LMWH) are used to treat cancer associated thrombosis. Furthermore, they could have an inhibitory effect on tumor progression.

International recommendations on the treatment and prophylaxis of the disease allow a better management of VTE in patients with cancer. Its prevalence is high, occurring in 15-20% of the patients. It remains the second leading cause of death after cancer. LMWH at therapeutic dosage for at least three months and preferably six months without oral bridging is the reference treatment for VTE, which showed a 50% reduction in the risk of recurrent thromboembolism without increasing the hemorrhagic risk. In case of VTE recurrence under LMWH treatment, the dose can be increased by 10%. Preliminary results suggest that the fibrin structure marker would predict the hemorrhagic or thromboembolic risk, and show that LMWH has a dose-dependent effect on fibrin structure. This marker is evaluated as a tool to guide the treatment of VTE by LMWH in patients with cancer.

Main objective. To assess the fibrin structure marker in the plasma of cancer patients, treated or not treated with LMWH at prophylactic doses at enrollment or therapeutic doses, to determine the venous thromboembolic risk. The occurrence of thromboembolic events in patients without treatment or of recurrent thromboembolic events in patients under LMWH treatment will be studied, depending on the location and type of cancer, metastases, and treatment of cancer.

Patients. At least 300 adult patients over 18 years with all types of malignancies documented before or during therapeutic treatment with LMWH for thromboembolic event. They will be monitored every month in consultation or during hospitalization in the Internal Medicine Department. The patients under prophylaxis with LMWH at enrollment will also be included and classified in the group of prophylactic patients. The patients who receive prophylactic treatment during will be included and classified in the group of untreated patients.

Will not be included: patients with sepsis, severe infections, pneumonia, surgery, suspected thromboembolic event related to catheter implantation, vitamin K antagonists (VKA) in progress, and those with impossible follow-up.

The study is conducted in compliance with French regulation after ethics approval, the authorization for processing personal data (Commission Nationale de l'Informatique et des Libertés, 8, rue Vivienne CS 30223 75083 Paris Cedex 02) receipt number 1867686 v 0, date 18 June 2015.

Reference algorithm. Patients will be supported for the diagnosis and specific treatment of cancer (with or without metastases), according to the daily practice. The baseline risk score is the Khorana score of clinical probability, based on clinical criteria. A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker.

Biological parameters to be studied. The following tests will be carried out on frozen citrated plasma or serum, without knowledge of the clinical data and the conclusion of a diagnostic of thromboembolic event:

  • Structure of the fibrin using coag-lysis method, measured at baseline and every month for all patients, by one site, using prototype assays
  • Anti-FXa activity measured at baseline and every month only for patients treated with LMWH at therapeutic doses,
  • FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance, Fibrin assay for inflammation and hypercoagulation evaluation, all measured at baseline and every 3 months for all patients.

Study Type

Observational

Enrollment (Actual)

389

Contacts and Locations

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

Study Locations

  • France
      • Colombes, France, 92701
        • Internal Medecine Department - Adults Pole and Hematology Laboratory Hôpital Louis Mourier (AP-HP)

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

Sampling Method

Non-Probability Sample

Study Population

Patients from Internal Medicine Department, in a French Hospital

Description

Inclusion Criteria:

  • patients with non-opposition to participate in the evaluation
  • patients from Internal Medicine Department
  • patients affected with all types of malignancies, treated or not with LMWH

Exclusion Criteria:

  • patients treated with VKA or with recent surgery (within one month)
  • patients with a condition known to cause a coagulation activation status other than cancer (sepsis, pneumonia,..)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I

Patients without LMWH treatment.

A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker.

The following assays will be performed for these patients :

  • Fibrin Structure measured at baseline and every month using prototype assays
  • Other markers activity : sFVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months.
Other: Fibrin Structure
Modifications of Fibrin Structure in patients who have developed VTE in comparison with patients without VTE.
Group II

Patients with LMWH treatment at prophylactic dose at enrollment only.

A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker.

The following assays will be performed for these patients :

  • Fibrin Structure measured at baseline and every month using prototype assays,
  • Anti-FXa activity measured at baseline and every month,
  • Other markers activity : FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months.
Other: Fibrin Structure
Modifications of Fibrin Structure in patients who have developed VTE in comparison with patients without VTE.
Group III

Patients with LMWH treatment at therapeutic dose.

A thromboembolic event has to be diagnosed according to standard imaging criteria (spiral computed tomography CT, proximal lower limb venous compression ultrasonography US) by clinicians who will not have knowledge of the result of the fibrin structure marker.

The following assays will be performed for these patients :

  • Fibrin Structure measured at baseline and every month using prototype assays,
  • Anti-FXa activity measured at baseline and every month,
  • Other markers activity : FVIII:C and TFPI for coagulation activation, DDimers and PAI-1 for fibrinolysis resistance and fibrin assay, all measured at baseline and every 3 months.
Other: Fibrin Structure
Modifications of Fibrin Structure in patients who have developed VTE in comparison with patients without VTE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic evolution of the optical density delta (ODD)
Time Frame: 36 Months

Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.

Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
36 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clotting time (s)
Time Frame: 36 Months

Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.

Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
36 Months
Fibrin formation time (s)
Time Frame: 36 Months

Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.

Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
36 Months
Lysis time (s)
Time Frame: 36 Months

Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.

Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
36 Months
Duration and level of the plateau (s)
Time Frame: 36 Months

Evolution of the optical density delta (ODD) and temporal parameters in patients who have developed VTE in comparison with those without VTE; variations of the Fibrin Structure parameters in comparison with either coagulation activation or fibrinolysis resistance assays, or fibrin assay.

Changes of the Fibrin structure parameters in patients of group III in comparison with group I and/or group II.
36 Months

Collaborators and Investigators

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

Sponsor

Diagnostica Stago R&D

Collaborators

Hopital Lariboisière
Hôpital Louis Mourier

Investigators

  • Principal Investigator: Isabelle Mahe, MD, PhD, Université of Paris 7 - Paris Diderot
  • Study Director: Geneviève Contant, PhD, Diagnostica Stago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

August 1, 2015

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FICT 2015-A00501-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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