Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung

Not Applicable

Completed

• Conditions: Cancer of Lung
• Interventions: Other: venous thromboembolism

• Registration Number: NCT02853188
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-04
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cancer of lung	venous thromboembolism	-

Primary Outcome Measures

Name	Time	Method
Tissue factor	2 years	Tissue factor is measured by kinetic-chromogenic assay
Venous thromboembolism occurence	2 years

Trial Locations

Locations (5)

: Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Centre hospitalier intercommunal de Créteil; 🇫🇷 Creteil, France

Centre hospitalier de Versailles; 🇫🇷 Le Chesnay, France

AP-HP Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hopital Foch; 🇫🇷 Suresnes, France