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

Neoplasms Clinical Trial

— CARMEN  

Official title:

National Evaluation of the Adherence to Recommendations of VTE Treatment in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362933
• Other study ID #: Version N°2.0 du 21/03/2011
• Status: Completed
• Phase: N/A
• First received: May 25, 2011
• Last updated: March 5, 2015
• Start date: May 2011
• Est. completion date: July 2012

Study information

• Verified date: March 2015
• Source: Floralis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasms
• Thromboembolism
• Venous Thromboembolism

Intervention

Procedure:
• VTE treatment in cancer patient description
proportion of patients treated for evolutive VTE according to international recommendations

Locations

Country	Name	City	State
France	CHR Annecy	Annecy
France	Centre Hospitalier Victor Dupouy	Argenteuil
France	CH AUCH	Auch
France	CH Beauvais	Beauvais
France	Institut Bergonie	Bordeaux
France	CHU de Brest	Brest
France	Centre François Baclesse	Caen
France	CHU de Caen	Caen
France	CH Antoine Gayraud Cedex 9	Carcassonne
France	Clinique du Parc CASTELNAU LE LEZ	Castelnau Le Lez
France	CH Chalons En Champagne	Chalons En Champagne
France	Pôle Santé Léonard de Vinci	Chambray-lès-Tours
France	Centre Jean Perrin Clcc	Clermont Ferrand
France	CHU	Clermont-Ferrand
France	Hopital Louis Mourier Colombes	Colombes
France	Polyclinique Saint come	Compiegne
France	CHU Bocage Dijon	Dijon
France	CHU	Grenoble
France	Ch Versailles Andre Maginot	Le Chesnay
France	CHRU Albert Calmette	Lille
France	CHRU Calmette	Lille
France	CHRU LILLE, Hôpital Huriez	Lille
France	Centre Hospitalier Edouard Herriot	Lyon
France	Centre Leon Berard LYON	Lyon
France	CH Saint Joseph Saint Luc	Lyon
France	Hopital Desgenettes LYON	Lyon
France	CHU La Timone Marseille	Marseille
France	Hôpital Nord Marseille	Marseille
France	Hopital Saint Joseph	Marseille
France	Institut Paoli Calmette Marseille	Marseille
France	Centre Régional de Lutte Contre le Cancer Val d'Aurelle	Montpellier
France	Centre de Lutte contre le Cancer (Centre René Gauducheau)	Nantes
France	CHU Hôtel-Dieu NANTES	Nantes
France	CHR Orleans	Orleans
France	Hopital de la Salpetriere Paris	Paris
France	Hôpital Kremlin Bicêtre	Paris
France	Hopital Saint Antoine Paris	Paris
France	Hopital Saint Louis Paris	Paris
France	Hopital Val de GRACE	Paris
France	CH Lyon Sud	Pierre Benite
France	CHU Rouen	Rouen
France	Centre Rene Hugunin institut curie	Saint cloud
France	Centre Hospitalier Mutualiste Site Etienne Dolet	Saint Nazaire
France	Clinique Charcot,	Sainte Foy-les-lyon
France	CHRU Strasbourg	Strasbourg
France	CH Valence	Valence
France	Ch Bretagne Atlantique	Vannes
France	Centre Hospitalier de Villefranche sur Saône	Villefranche sur Saône
France	Institut Gustave Roussy	Villejuif

Sponsors (4)

Lead Sponsor	Collaborator
Floralis	Centre Hospitalier Universitaire, Amiens, Groupe Francophone Thrombose et Cancer (GFTC), University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (7)

Blom JW, Vanderschoot JP, Oostindiër 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the adherence to recommendations of VTE treatment in cancer patients	Proportion of patients treated for evolutive VTE according to international recommandations Patients could be hospitalised or could be out patient	At baseline (J0)	No
Secondary	Evaluation of VTE disease according to cancer diagnosis (proportion of SVT (Superficial Venous Thrombosis), DVT (Deep Venous Thrombosis), PE (Pulmonary Embolism)	Percentage of VTE (PE,DVT,SVT)and cancer type	At baseline (J0)	No
Secondary	Proportion of asymptomatic VTE disease for this population	percentage of VTE and cancer status (local, metastatic)	At baseline (J0)	No
Secondary	Feasibility of self injections for VTE treatment in cancer patients.	percentage of patients practising self injections	At baseline (J0)	No
Secondary	Proportion of patients with catheter thrombosis	Percentage of patients receiving novel cancer therapies	At baseline (J0)	No

External Links

•   American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer.
•   Traitement curatif de la maladie thromboembolique veineuse. Prévention et traitement des thromboses veineuses sur cathéter