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

NCT01362933 | Completed

• 1 other identifier: Version N°2.0 du 21/03/2011
• Study Type: observational
• Target: 502
• Locations: 1 country
• Sites: 49

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.

Conditions

Neoplasms; Venous Thromboembolism

Keywords

PE; DVT; SVT; LMWH; VKA; international Venous Thromboembolism Recommendations

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Evaluation of VTE disease according to cancer diagnosis (proportion of SVT (Superficial Venous Thrombosis), DVT (Deep Venous Thrombosis), PE (Pulmonary Embolism)

  At baseline (J0)

• Proportion of asymptomatic VTE disease for this population

  At baseline (J0)

• Feasibility of self injections for VTE treatment in cancer patients.

  At baseline (J0)

• Proportion of patients with catheter thrombosis

  At baseline (J0)

Study Arms (1)

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

Interventions

VTE treatment in cancer patient description PROCEDURE

proportion of patients treated for evolutive VTE according to international recommendations

VTE treatment in cancer patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Patient already included in a trial studying antithrombotic therapy
• Patient refusing the study
• Patient under 18 and/or not competent to give informed consent

Sponsors & Collaborators

• Floralis: lead
• Centre Hospitalier Universitaire, Amiens: collaborator
• Groupe Francophone Thrombose et Cancer (GFTC): collaborator
• University Hospital, Grenoble: collaborator

Study Sites (49)

CHR Annecy

Annecy, 74374, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, 95100, France

Location

CH AUCH

Auch, 32000, France

Location

CH Beauvais

Beauvais, 60021, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CHU de Brest

Brest, 29609, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre François Baclesse

Caen, 14076, France

Location

CH Antoine Gayraud Cedex 9

Carcassonne, 11890, France

Location

Clinique du Parc CASTELNAU LE LEZ

Castelnau-le-Lez, 34170, France

Location

Pôle Santé Léonard de Vinci

Chambray-lès-Tours, 37175, France

Location

CH Chalons En Champagne

Châlons-en-Champagne, 51005, France

Location

Centre Jean Perrin Clcc

Clermont-Ferrand, 63000, France

Location

CHU

Clermont-Ferrand, 63057, France

Location

Hopital Louis Mourier Colombes

Colombes, 92701, France

Location

Polyclinique Saint come

Compiègne, 60200, France

Location

CHU Bocage Dijon

Dijon, 21079, France

Location

CHU

Grenoble, 38043, France

Location

Ch Versailles Andre Maginot

Le Chesnay, 78157, France

Location

CHRU Calmette

Lille, 59037, France

Location

CHRU LILLE, Hôpital Huriez

Lille, 59037, France

Location

CHRU Albert Calmette

Lille, France

Location

Centre Hospitalier Edouard Herriot

Lyon, 69003, France

Location

Hopital Desgenettes LYON

Lyon, 69003, France

Location

Centre Leon Berard LYON

Lyon, 69008, France

Location

CH Saint Joseph Saint Luc

Lyon, 69365, France

Location

Institut Paoli Calmette Marseille

Marseille, 13273, France

Location

Hopital Saint Joseph

Marseille, 13285, France

Location

CHU La Timone Marseille

Marseille, 13385, France

Location

Hôpital Nord Marseille

Marseille, 13915, France

Location

Centre Régional de Lutte Contre le Cancer Val d'Aurelle

Montpellier, 34298, France

Location

CHU Hôtel-Dieu NANTES

Nantes, 44093, France

Location

Centre de Lutte contre le Cancer (Centre René Gauducheau)

Nantes, 44805, France

Location

CHR Orleans

Orléans, 45067, France

Location

Hopital Saint Louis Paris

Paris, 75010, France

Location

Hopital Saint Antoine Paris

Paris, 75012, France

Location

Hopital de la Salpetriere Paris

Paris, 75013, France

Location

Hopital Val de GRACE

Paris, 75230, France

Location

Hôpital Kremlin Bicêtre

Paris, 94275, France

Location

CH Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Rouen

Rouen, 76031, France

Location

Centre Rene Hugunin institut curie

Saint-Cloud, 92210, France

Location

Centre Hospitalier Mutualiste Site Etienne Dolet

Saint-Nazaire, 44 600, France

Location

Clinique Charcot,

Sainte-Foy-lès-Lyon, 69110, France

Location

CHRU Strasbourg

Strasbourg, 67091, France

Location

CH Valence

Valence, 26953, France

Location

Ch Bretagne Atlantique

Vannes, 56017, France

Location

Centre Hospitalier de Villefranche sur Saône

Villefranche-sur-Saône, 69400, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (7)

• 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.

  PMID: 17918266 BACKGROUND

• 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.

  PMID: 10499070 BACKGROUND

• 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.

  PMID: 16284987 BACKGROUND

• 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.

  PMID: 16460435 BACKGROUND

• 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.

  PMID: 16505267 BACKGROUND

• 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.

  PMID: 10737280 BACKGROUND

• 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.

  PMID: 16549834 BACKGROUND

Related Links

• American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer.

MeSH Terms

Conditions

Neoplasms; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marie-Antoinette SEVESTRE, MD

  Centre Hospitalier Universitaire, Amiens

  PRINCIPAL INVESTIGATOR

• Dominique FARGE BANCEL, MD

  GFTC

  STUDY DIRECTOR

• Jean Luc BOSSON, MD

  University Hospital, Grenoble

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: June 1, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

FR (49)