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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
      • 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 Côme
      • 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 Berard Lyon
      • Lyon, France, 69365
        • CH Saint Joseph Saint Luc
      • Marseille, France, 13285
        • Hôpital 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 Orléans
      • Paris, France, 94275
        • Hôpital Kremlin Bicêtre
      • Paris, France, 75012
        • Hôpital Saint Antoine Paris
      • Paris, France, 75010
        • Hôpital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: VTE treatment in cancer patient description
proportion of patients treated for evolutive VTE according to international recommendations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Floralis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre Hospitalier Universitaire, Amiens
University Hospital, Grenoble
Groupe Francophone Thrombose et Cancer (GFTC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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