Cancer of LungFT-KBPNCT02853188
Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung
A study testing venous thromboembolism in people with Cancer of Lung, run by Hopital Foch at 5 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Lung
- What is being tested?
- venous thromboembolism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 5 sitesFrance
- Study dates
- 4 Dec 2014to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre hospitalier intercommunal de Créteil
Créteil, 94010
Centre hospitalier de Versailles
Le Chesnay, 78157
: Institut Mutualiste Montsouris
Paris, 75014
AP-HP Hôpital Européen Georges Pompidou
Paris, 75015
Hopital Foch
Suresnes, 92150
About this study
Official title: 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.
- Conditions
- Cancer of Lung
- Being tested
- venous thromboembolism
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous thromboembolismOther
| Study group | Role | What they receive |
|---|---|---|
| cancer of lung | Experimental | Not described Receives: Other: venous thromboembolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism occurence
Measured: 2 years
Tissue factor
Tissue factor is measured by kinetic-chromogenic assay
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start4 Dec 2014
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc VASSE, PhD, Study director, Hopitak Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853188
- Sponsor's protocol ID
- 2014/21
- Other IDs
- 2014-A00881-46
- Acronym
- FT-KBP
- Status last verified
- Aug 2019
- First submitted
- 27 Jul 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Measure of the Plasma Tissue Factor Allow to Predict a Venous Thromboembolism Episode for Patients Presenting a Primitive Lung Cancer?
- ClinicalTrials.gov ID
- NCT02853188
- Acronym / sponsor ID
- FT-KBP / 2014/21
- Conditions
- Cancer of Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 4 Dec 2014 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer of lung | Experimental | Other: venous thromboembolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venous thromboembolism | Other | cancer of lung |
Primary outcome
Venous thromboembolism occurence
Time frame: 2 years
Tissue factor
Time frame: 2 years
Tissue factor is measured by kinetic-chromogenic assay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc VASSE, PhD study director
Hopitak Foch
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venous thromboembolism in people with Cancer of Lung, run by Hopital Foch at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism occurence (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.