Back to resultsMeasure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung (FT-KBP)
Primary Purpose
Cancer of Lung
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
venous thromboembolism
Sponsored by
About this trial
This is an interventional prevention trial for Cancer of Lung
Eligibility Criteria
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)
Sites / Locations
- Centre hospitalier intercommunal de Créteil
- Centre hospitalier de Versailles
- : Institut Mutualiste Montsouris
- AP-HP Hôpital Européen Georges Pompidou
- Hopital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cancer of lung
Arm Description
Outcomes
Primary Outcome Measures
Venous thromboembolism occurence
Tissue factor
Tissue factor is measured by kinetic-chromogenic assay
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02853188
Brief Title
Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung
Acronym
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?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 4, 2014 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Lung
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
315 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cancer of lung
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
venous thromboembolism
Primary Outcome Measure Information:
Title
Venous thromboembolism occurence
Time Frame
2 years
Title
Tissue factor
Description
Tissue factor is measured by kinetic-chromogenic assay
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc VASSE, PhD
Organizational Affiliation
Hopitak Foch
Official's Role
Study Director
Facility Information:
Facility Name
Centre hospitalier intercommunal de Créteil
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
: Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
AP-HP Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung
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