- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01362933
National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients (CARMEN)
March 5, 2015 updated by: Floralis
National Evaluation of the Adherence to Recommendations of VTE Treatment in Cancer Patients
Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months.
International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
502
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Annecy, France, 74374
- CHR Annecy
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Argenteuil, France, 95100
- Centre Hospitalier Victor Dupouy
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Auch, France, 32000
- CH Auch
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Beauvais, France, 60021
- CH Beauvais
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Bordeaux, France, 33076
- Institut Bergonie
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Brest, France, 29609
- CHU de Brest
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Caen, France, 14076
- Centre François Baclesse
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Caen, France, 14033
- CHU de Caen
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Carcassonne, France, 11890
- CH Antoine Gayraud Cedex 9
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Castelnau Le Lez, France, 34170
- Clinique du Parc CASTELNAU LE LEZ
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Chalons En Champagne, France, 51005
- CH Chalons En Champagne
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Chambray-lès-Tours, France, 37175
- Pole Sante Leonard de Vinci
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Clermont Ferrand, France, 63000
- Centre Jean Perrin CLCC
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Clermont-Ferrand, France, 63057
- CHU
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Colombes, France, 92701
- Hopital Louis Mourier Colombes
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Compiegne, France, 60200
- Polyclinique Saint Come
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Dijon, France, 21079
- CHU Bocage Dijon
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Grenoble, France, 38043
- CHU
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Le Chesnay, France, 78157
- Ch Versailles Andre Maginot
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Lille, France, 59037
- CHRU Calmette
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Lille, France, 59037
- CHRU LILLE, Hôpital Huriez
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Lille, France
- CHRU Albert Calmette
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Lyon, France, 69003
- Centre Hospitalier Edouard Herriot
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Lyon, France, 69003
- Hopital Desgenettes LYON
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Lyon, France, 69008
- Centre Léon Bérard Lyon
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Lyon, France, 69365
- CH Saint Joseph Saint Luc
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Marseille, France, 13285
- Hopital Saint Joseph
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Marseille, France, 13273
- Institut Paoli Calmette Marseille
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Marseille, France, 13385
- CHU La Timone Marseille
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Marseille, France, 13915
- Hôpital Nord Marseille
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Montpellier, France, 34298
- Centre Regional de Lutte contre le Cancer Val d'Aurelle
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Nantes, France, 44093
- CHU Hôtel-Dieu NANTES
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Nantes, France, 44805
- Centre de Lutte contre le Cancer (Centre René Gauducheau)
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Orleans, France, 45067
- CHR Orleans
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Paris, France, 94275
- Hôpital Kremlin Bicetre
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Paris, France, 75012
- Hôpital Saint Antoine PARIS
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Paris, France, 75010
- Hopital Saint Louis Paris
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Paris, France, 75013
- Hopital de la Salpetriere Paris
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Paris, France, 75230
- Hopital Val de GRACE
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Pierre Benite, France, 69495
- CH Lyon Sud
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Rouen, France, 76031
- CHU Rouen
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Saint Nazaire, France, 44 600
- Centre Hospitalier Mutualiste Site Etienne Dolet
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Saint cloud, France, 92210
- Centre Rene Hugunin institut curie
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Sainte Foy-les-lyon, France, 69110
- Clinique Charcot,
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Strasbourg, France, 67091
- CHRU Strasbourg
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Valence, France, 26953
- CH Valence
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Vannes, France, 56017
- CH Bretagne Atlantique
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Villefranche sur Saône, France, 69400
- Centre Hospitalier de Villefranche sur Saone
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Villejuif, France, 94805
- Institut Gustave Roussy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with cancer present in the clinic, hospital, out patients diagnosed with a VTE during the 6 previous months
Description
Inclusion Criteria:
All patients with cancer present in the clinic, hospital, out patients diagnosed with a VTE during the 6 previous months. VTE can be symptomatic or asymptomatic, can be located close to a central line, and of any type (DVT, PE, SVT)
Exclusion Criteria:
- Patient already included in a trial studying antithrombotic therapy
- Patient refusing the study
- Patient under 18 and/or not competent to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
VTE treatment in cancer patient
All patients with cancer present in the clinic, hospital, out patient diagnosed with a VTE during the 6 previous months.
|
proportion of patients treated for evolutive VTE according to international recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the adherence to recommendations of VTE treatment in cancer patients
Time Frame: At baseline (J0)
|
Proportion of patients treated for evolutive VTE according to international recommandations Patients could be hospitalised or could be out patient
|
At baseline (J0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of VTE disease according to cancer diagnosis (proportion of SVT (Superficial Venous Thrombosis), DVT (Deep Venous Thrombosis), PE (Pulmonary Embolism)
Time Frame: At baseline (J0)
|
Percentage of VTE (PE,DVT,SVT)and cancer type
|
At baseline (J0)
|
Proportion of asymptomatic VTE disease for this population
Time Frame: At baseline (J0)
|
percentage of VTE and cancer status (local, metastatic)
|
At baseline (J0)
|
Feasibility of self injections for VTE treatment in cancer patients.
Time Frame: At baseline (J0)
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percentage of patients practising self injections
|
At baseline (J0)
|
Proportion of patients with catheter thrombosis
Time Frame: At baseline (J0)
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Percentage of patients receiving novel cancer therapies
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At baseline (J0)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marie-Antoinette SEVESTRE, MD, Centre Hospitalier Universitaire, Amiens
- Study Director: Dominique FARGE BANCEL, MD, GFTC
- Study Director: Jean Luc BOSSON, MD, University Hospital, Grenoble
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH. Frequency, risk factors, and trends for venous thromboembolism among hospitalized cancer patients. Cancer. 2007 Nov 15;110(10):2339-46. doi: 10.1002/cncr.23062.
- Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
- Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect on survival among patients with common cancers. Arch Intern Med. 2006 Feb 27;166(4):458-64. doi: 10.1001/archinte.166.4.458.
- Levitan N, Dowlati A, Remick SC, Tahsildar HI, Sivinski LD, Beyth R, Rimm AA. Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy. Risk analysis using Medicare claims data. Medicine (Baltimore). 1999 Sep;78(5):285-91. doi: 10.1097/00005792-199909000-00001.
- Blom JW, Vanderschoot JP, Oostindier MJ, Osanto S, van der Meer FJ, Rosendaal FR. Incidence of venous thrombosis in a large cohort of 66,329 cancer patients: results of a record linkage study. J Thromb Haemost. 2006 Mar;4(3):529-35. doi: 10.1111/j.1538-7836.2006.01804.x.
- Khorana AA, Francis CW, Culakova E, Lyman GH. Risk factors for chemotherapy-associated venous thromboembolism in a prospective observational study. Cancer. 2005 Dec 15;104(12):2822-9. doi: 10.1002/cncr.21496.
- Lee AY, Levine MN, Butler G, Webb C, Costantini L, Gu C, Julian JA. Incidence, risk factors, and outcomes of catheter-related thrombosis in adult patients with cancer. J Clin Oncol. 2006 Mar 20;24(9):1404-8. doi: 10.1200/JCO.2005.03.5600.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
May 25, 2011
First Submitted That Met QC Criteria
May 27, 2011
First Posted (Estimate)
June 1, 2011
Study Record Updates
Last Update Posted (Estimate)
March 6, 2015
Last Update Submitted That Met QC Criteria
March 5, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Version N°2.0 du 21/03/2011
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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