Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung
FT-KBP
Does the Measure of the Plasma Tissue Factor Allow to Predict a Venous Thromboembolism Episode for Patients Presenting a Primitive Lung Cancer?
2 other identifiers
interventional
315
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2014
CompletedFirst Submitted
Initial submission to the registry
July 27, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2018
CompletedAugust 15, 2019
August 1, 2019
4 years
July 27, 2016
August 13, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Venous thromboembolism occurence
2 years
Tissue factor
Tissue factor is measured by kinetic-chromogenic assay
2 years
Study Arms (1)
cancer of lung
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (5)
Centre hospitalier intercommunal de Créteil
Créteil, 94010, France
Centre hospitalier de Versailles
Le Chesnay, 78157, France
: Institut Mutualiste Montsouris
Paris, 75014, France
AP-HP Hôpital Européen Georges Pompidou
Paris, 75015, France
Hopital Foch
Suresnes, 92150, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marc VASSE, PhD
Hopitak Foch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2016
First Posted
August 2, 2016
Study Start
December 4, 2014
Primary Completion
December 20, 2018
Study Completion
December 20, 2018
Last Updated
August 15, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share