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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01362933
Other study ID # Version N°2.0 du 21/03/2011
Secondary ID
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


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
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