- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04196790
Development of a Model to Predict the Risk of Venous Thromboembolic Events in Patients With Metastatic Bronchopulmonary Cancer (LUCAAT)
Développement d'un modèle prédictif du Risque de Survenue d'évènements Thromboemboliques Veineux Chez Les Patients Atteints de Cancer Broncho-pulmonaire métastatique
Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.
In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE.
The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.
Study Overview
Status
Conditions
Detailed Description
Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.
In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE, particularly in adenocarcinoma.
The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Francis COUTURAUD
- Phone Number: 02-98-34-78-26
- Email: francis.couturuad@chu-brest.fr
Study Locations
-
-
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Brest, France, 29609
- Recruiting
- CHRU de Brest
-
Contact:
- Francis COUTURAUD
- Email: francis.couturaud@chu-brest.fr
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Morlaix, France, 29600
- Not yet recruiting
- CH des Pays de Morlaix
-
Contact:
- Christophe ROGE
- Email: croge@ch-morlaix.fr
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Quimper, France, 29000
- Not yet recruiting
- CHIC de Quimper
-
Contact:
- Florence VERGNE
- Email: florence.vergne@ch-cornouaille.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- metastatic broncho-pulmonary cancer
- age ≥18 years
- who are eligible for chemotherapy
- non opposition obtained
Exclusion Criteria:
- age <18 years
- pregnancy, breast feeding
- VTE in the past 6 months or at the time of cancer diagnosis
- surgery in the past 3 months
- refusal to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
venous thromboembolism at 12 months
Time Frame: 12 months
|
objectively diagnosed VTE based on validated diagnostic tests
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: one year
|
overall survival
|
one year
|
survival without progression
Time Frame: one year
|
survival without progression
|
one year
|
VTE at 6 months
Time Frame: 6 months
|
VTE at 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LUCAAT ( 29BRC19. 0224)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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