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

Cancer of Lung Clinical Trial

— FT-KBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853188
• Other study ID #: 2014/21
• Secondary ID: 2014-A00881-46
• Status: Completed
• Phase: N/A
• Start date: December 4, 2014
• Est. completion date: December 20, 2018

Study information

• Verified date: August 2019
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer of Lung
• Lung Neoplasms
• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• venous thromboembolism

Locations

Country	Name	City	State
France	Centre hospitalier intercommunal de Créteil	Creteil
France	Centre hospitalier de Versailles	Le Chesnay
France	: Institut Mutualiste Montsouris	Paris
France	AP-HP Hôpital Européen Georges Pompidou	Paris
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolism occurence		2 years
Primary	Tissue factor	Tissue factor is measured by kinetic-chromogenic assay	2 years