Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung (FT-KBP)

August 13, 2019 updated by: Hopital Foch

Does the Measure of the Plasma Tissue Factor Allow to Predict a Venous Thromboembolism Episode for Patients Presenting a Primitive Lung Cancer?

The aim of the study is to evaluate if the plasma activity of the tissue factor at the time of the diagnosis of a lung cancer, before any treatment, or after the treatment of induction (surgery or two first cures of chemotherapy), can be a predictive factor of venous thromboembolism disease in the year which follows the diagnosis, independently of the other parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

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 Locations

  • France
      • Creteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Le Chesnay, France, 78157
        • Centre Hospitalier De Versailles
      • Paris, France, 75015
        • AP-HP Hopital Europeen Georges Pompidou
      • Paris, France, 75014
        • : Institut Mutualiste Montsouris
      • Suresnes, France, 92150
        • Hopital FOCH

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:

  • Patients of more than 18 years old
  • Patients with cancer of lung diagnosis carried for less than 2 months and which were not handled yet, either by surgery or by chemotherapy, or by radiotherapy
  • Patients whose life expectancy is considered 3-month-old a superior
  • Patients having given writed consent
  • Patients affiliated to a national insurance scheme or benefiting from such a diet
  • Patients having received a treatment (processing) anticoagulating in preventive dose if this treatment was stopped at least 3 days before the 1st taking or patients not receiving an anticoagulating treatment (in case of curative treatment, the latter was before arrested at least 3 months

Exclusion Criteria:

  • Patients having a hepatic disease with coagulation disorders
  • Patients under anticoagulants with dose guardian in 3 months preceding the study or presenting an active infection
  • Patients having a history of other cancer considered as cured and diagnosed for less than 5 years (with the exception of the patients operated for an in situ carcinoma of the neck of the womb or the patients having undergone the excision of a squamous-cell carcinoma)

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cancer of lung
Other: venous thromboembolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous thromboembolism occurence
Time Frame: 2 years
2 years
Tissue factor
Time Frame: 2 years
Tissue factor is measured by kinetic-chromogenic assay
2 years

Collaborators and Investigators

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

Sponsor

Hopital Foch

Investigators

  • Study Director: Marc VASSE, PhD, Hopitak Foch

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)

December 4, 2014

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/21
  • 2014-A00881-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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