Clinical trial NCT01362933: National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients
Official title: National Evaluation of the Adherence to Recommendations of VTE Treatment in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Venous Thromboembolism
Keywords: PE
DVT
SVT
LMWH
VKA
international Venous Thromboembolism Recommendations
Lead sponsor: Floralis
Sponsor class: INDUSTRY
Collaborators: name: Centre Hospitalier Universitaire, Amiens
name: Groupe Francophone Thrombose et Cancer (GFTC)
name: University Hospital, Grenoble
First posted: 2011-06-01
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility 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

Primary outcomes:
measure: Evaluation of the adherence to recommendations of VTE treatment in cancer patients
timeFrame: At baseline (J0)
Secondary outcomes:
measure: Evaluation of VTE disease according to cancer diagnosis (proportion of SVT (Superficial Venous Thrombosis), DVT (Deep Venous Thrombosis), PE (Pulmonary Embolism)
timeFrame: At baseline (J0)
measure: Proportion of asymptomatic VTE disease for this population
timeFrame: At baseline (J0)
measure: Feasibility of self injections for VTE treatment in cancer patients.
timeFrame: At baseline (J0)
measure: Proportion of patients with catheter thrombosis
timeFrame: At baseline (J0)
Other outcomes:
Locations:
city: Annecy
country: France
facility: CHR Annecy
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Auch
country: France
facility: CH AUCH
city: Beauvais
country: France
facility: CH Beauvais
city: Bordeaux
country: France
facility: Institut Bergonie
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de Caen
city: Caen
country: France
facility: Centre François Baclesse
city: Carcassonne
country: France
facility: CH Antoine Gayraud Cedex 9
city: Castelnau Le Lez
country: France
facility: Clinique du Parc CASTELNAU LE LEZ
city: Chalons En Champagne
country: France
facility: CH Chalons En Champagne
city: Chambray-lès-Tours
country: France
facility: Pôle Santé Léonard de Vinci
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin Clcc
city: Clermont-Ferrand
country: France
facility: CHU
city: Colombes
country: France
facility: Hopital Louis Mourier Colombes
city: Compiegne
country: France
facility: Polyclinique Saint come
city: Dijon
country: France
facility: CHU Bocage Dijon
city: Grenoble
country: France
facility: CHU
city: Le Chesnay
country: France
facility: Ch Versailles Andre Maginot
city: Lille
country: France
facility: CHRU Calmette
city: Lille
country: France
facility: CHRU LILLE, Hôpital Huriez
city: Lille
country: France
facility: CHRU Albert Calmette
city: Lyon
country: France
facility: Centre Hospitalier Edouard Herriot
city: Lyon
country: France
facility: Hopital Desgenettes LYON
city: Lyon
country: France
facility: Centre Leon Berard LYON
city: Lyon
country: France
facility: CH Saint Joseph Saint Luc
city: Marseille
country: France
facility: Institut Paoli Calmette Marseille
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Marseille
country: France
facility: CHU La Timone Marseille
city: Marseille
country: France
facility: Hôpital Nord Marseille
city: Montpellier
country: France
facility: Centre Régional de Lutte Contre le Cancer Val d'Aurelle
city: Nantes
country: France
facility: CHU Hôtel-Dieu NANTES
city: Nantes
country: France
facility: Centre de Lutte contre le Cancer (Centre René Gauducheau)
city: Orleans
country: France
facility: CHR Orleans
city: Paris
country: France
facility: Hopital Saint Louis Paris
city: Paris
country: France
facility: Hopital Saint Antoine Paris
city: Paris
country: France
facility: Hopital de la Salpetriere Paris
city: Paris
country: France
facility: Hopital Val de GRACE
city: Paris
country: France
facility: Hôpital Kremlin Bicêtre
city: Pierre Benite
country: France
facility: CH Lyon Sud
city: Rouen
country: France
facility: CHU Rouen
city: Saint cloud
country: France
facility: Centre Rene Hugunin institut curie
city: Saint Nazaire
country: France
facility: Centre Hospitalier Mutualiste Site Etienne Dolet
city: Sainte Foy-les-lyon
country: France
facility: Clinique Charcot,
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Valence
country: France
facility: CH Valence
city: Vannes
country: France
facility: Ch Bretagne Atlantique
city: Villefranche sur Saône
country: France
facility: Centre Hospitalier de Villefranche sur Saône
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Hospitalier Universitaire, Amiens
name: Marie-Antoinette SEVESTRE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GFTC
name: Dominique FARGE BANCEL, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Grenoble
name: Jean Luc BOSSON, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1002/cncr.23062.
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. doi: 10.1097/00005792-199909000-00001.
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. doi: 10.1002/cncr.21496.
citation: 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.
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. doi: 10.1001/archinte.166.4.458.
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. doi: 10.1001/archinte.160.6.809.
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. doi: 10.1200/JCO.2005.03.5600.