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

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

      • Annecy, France, 74374
        • CHR Annecy
      • Argenteuil, France, 95100
        • Centre Hospitalier Victor Dupouy
      • Auch, France, 32000
        • CH Auch
      • Beauvais, France, 60021
        • CH Beauvais
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Brest, France, 29609
        • CHU de Brest
      • Caen, France, 14076
        • Centre François Baclesse
      • Caen, France, 14033
        • CHU de Caen
      • Carcassonne, France, 11890
        • CH Antoine Gayraud Cedex 9
      • Castelnau Le Lez, France, 34170
        • Clinique du Parc CASTELNAU LE LEZ
      • Chalons En Champagne, France, 51005
        • CH Chalons En Champagne
      • Chambray-lès-Tours, France, 37175
        • Pole Sante Leonard de Vinci
      • Clermont Ferrand, France, 63000
        • Centre Jean Perrin CLCC
      • Clermont-Ferrand, France, 63057
        • CHU
      • Colombes, France, 92701
        • Hopital Louis Mourier Colombes
      • Compiegne, France, 60200
        • Polyclinique Saint Come
      • Dijon, France, 21079
        • CHU Bocage Dijon
      • Grenoble, France, 38043
        • CHU
      • Le Chesnay, France, 78157
        • Ch Versailles Andre Maginot
      • Lille, France, 59037
        • CHRU Calmette
      • Lille, France, 59037
        • CHRU LILLE, Hôpital Huriez
      • Lille, France
        • CHRU Albert Calmette
      • Lyon, France, 69003
        • Centre Hospitalier Edouard Herriot
      • Lyon, France, 69003
        • Hopital Desgenettes LYON
      • Lyon, France, 69008
        • Centre Léon Bérard Lyon
      • Lyon, France, 69365
        • CH Saint Joseph Saint Luc
      • Marseille, France, 13285
        • Hopital Saint Joseph
      • Marseille, France, 13273
        • Institut Paoli Calmette Marseille
      • Marseille, France, 13385
        • CHU La Timone Marseille
      • Marseille, France, 13915
        • Hôpital Nord Marseille
      • Montpellier, France, 34298
        • Centre Regional de Lutte contre le Cancer Val d'Aurelle
      • Nantes, France, 44093
        • CHU Hôtel-Dieu NANTES
      • Nantes, France, 44805
        • Centre de Lutte contre le Cancer (Centre René Gauducheau)
      • Orleans, France, 45067
        • CHR Orleans
      • Paris, France, 94275
        • Hôpital Kremlin Bicetre
      • Paris, France, 75012
        • Hôpital Saint Antoine PARIS
      • Paris, France, 75010
        • Hopital Saint Louis Paris
      • Paris, France, 75013
        • Hopital de la Salpetriere Paris
      • Paris, France, 75230
        • Hopital Val de GRACE
      • Pierre Benite, France, 69495
        • CH Lyon Sud
      • Rouen, France, 76031
        • CHU Rouen
      • Saint Nazaire, France, 44 600
        • Centre Hospitalier Mutualiste Site Etienne Dolet
      • Saint cloud, France, 92210
        • Centre Rene Hugunin institut curie
      • Sainte Foy-les-lyon, France, 69110
        • Clinique Charcot,
      • Strasbourg, France, 67091
        • CHRU Strasbourg
      • Valence, France, 26953
        • CH Valence
      • Vannes, France, 56017
        • CH Bretagne Atlantique
      • Villefranche sur Saône, France, 69400
        • Centre Hospitalier de Villefranche sur Saone
      • Villejuif, France, 94805
        • Institut Gustave Roussy

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)
percentage of patients practising self injections
At baseline (J0)
Proportion of patients with catheter thrombosis
Time Frame: At baseline (J0)
Percentage of patients receiving novel cancer therapies
At baseline (J0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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

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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