National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients (CARMEN)

This study has been completed.
Sponsor:
Collaborators:
Centre Hospitalier Universitaire, Amiens
Groupe Francophone Thrombose et Cancer (GFTC)
University Hospital, Grenoble
Information provided by (Responsible Party):
Floralis
ClinicalTrials.gov Identifier:
NCT01362933
First received: May 25, 2011
Last updated: March 5, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Neoplasms
Venous Thromboembolism
Procedure: VTE treatment in cancer patient description

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Evaluation of the Adherence to Recommendations of VTE Treatment in Cancer Patients

Resource links provided by NLM:


Further study details as provided by Floralis:

Primary Outcome Measures:
  • Evaluation of the adherence to recommendations of VTE treatment in cancer patients [ Time Frame: At baseline (J0) ] [ Designated as safety issue: No ]
    Proportion of patients treated for evolutive VTE according to international recommandations Patients could be hospitalised or could be out patient


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Percentage of VTE (PE,DVT,SVT)and cancer type

  • Proportion of asymptomatic VTE disease for this population [ Time Frame: At baseline (J0) ] [ Designated as safety issue: No ]
    percentage of VTE and cancer status (local, metastatic)

  • Feasibility of self injections for VTE treatment in cancer patients. [ Time Frame: At baseline (J0) ] [ Designated as safety issue: No ]
    percentage of patients practising self injections

  • Proportion of patients with catheter thrombosis [ Time Frame: At baseline (J0) ] [ Designated as safety issue: No ]
    Percentage of patients receiving novel cancer therapies


Enrollment: 502
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362933

  Show 49 Study Locations
Sponsors and Collaborators
Floralis
Centre Hospitalier Universitaire, Amiens
Groupe Francophone Thrombose et Cancer (GFTC)
University Hospital, Grenoble
Investigators
Principal Investigator: Marie-Antoinette SEVESTRE, MD Centre Hospitalier Universitaire, Amiens
Study Director: Dominique FARGE BANCEL, MD GFTC
Study Director: Jean Luc BOSSON, MD CHU GRENOBLE
  More Information

Additional Information:
Publications:

Responsible Party: Floralis
ClinicalTrials.gov Identifier: NCT01362933     History of Changes
Other Study ID Numbers: Version N°2.0 du 21/03/2011
Study First Received: May 25, 2011
Last Updated: March 5, 2015
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority

Keywords provided by Floralis:
PE
DVT
SVT
LMWH
VKA
international Venous Thromboembolism Recommendations

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2015