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CompletedNCT01362933CARMENUpdated Mar 6, 2015

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

An observational study in Neoplasms and Venous Thromboembolism, sponsored by Floralis. Completed at 49 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by Floralis · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
502
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Neoplasms
  • Venous Thromboembolism

Keywords

  • PE
  • DVT
  • SVT
  • LMWH
  • VKA
  • international Venous Thromboembolism Recommendations
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In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 502 is above the median of 202 across 1,742 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Floralis is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
502 participants (actual)

Groups and cohorts

  • 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

  • ProcedureVTE treatment in cancer patient description

    proportion of patients treated for evolutive VTE according to international recommendations

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What researchers measure

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

    Time frame: At baseline (J0)

Secondary outcomes

  1. 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

    Time frame: At baseline (J0)

  2. Proportion of asymptomatic VTE disease for this population

    percentage of VTE and cancer status (local, metastatic)

    Time frame: At baseline (J0)

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

    percentage of patients practising self injections

    Time frame: At baseline (J0)

  4. Proportion of patients with catheter thrombosis

    Percentage of patients receiving novel cancer therapies

    Time frame: At baseline (J0)

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Study locations

49 sites
  • CHR Annecy
    Annecy, 74374, France
  • Centre Hospitalier Victor Dupouy
    Argenteuil, 95100, France
  • CH AUCH
    Auch, 32000, France
  • CH Beauvais
    Beauvais, 60021, France
  • Institut Bergonie
    Bordeaux, 33076, France
  • CHU de Brest
    Brest, 29609, France
  • CHU de Caen
    Caen, 14033, France
  • Centre François Baclesse
    Caen, 14076, France
  • CH Antoine Gayraud Cedex 9
    Carcassonne, 11890, France
  • Clinique du Parc CASTELNAU LE LEZ
    Castelnau-le-Lez, 34170, France
  • Pôle Santé Léonard de Vinci
    Chambray-lès-Tours, 37175, France
  • CH Chalons En Champagne
    Châlons-en-Champagne, 51005, France
  • Centre Jean Perrin Clcc
    Clermont-Ferrand, 63000, France
  • CHU
    Clermont-Ferrand, 63057, France
  • Hopital Louis Mourier Colombes
    Colombes, 92701, France
  • Polyclinique Saint come
    Compiègne, 60200, France
  • CHU Bocage Dijon
    Dijon, 21079, France
  • CHU
    Grenoble, 38043, France
  • Ch Versailles Andre Maginot
    Le Chesnay, 78157, France
  • CHRU Calmette
    Lille, 59037, France
  • CHRU LILLE, Hôpital Huriez
    Lille, 59037, France
  • CHRU Albert Calmette
    Lille, France
  • Centre Hospitalier Edouard Herriot
    Lyon, 69003, France
  • Hopital Desgenettes LYON
    Lyon, 69003, France
  • Centre Leon Berard LYON
    Lyon, 69008, France
  • CH Saint Joseph Saint Luc
    Lyon, 69365, France
  • Institut Paoli Calmette Marseille
    Marseille, 13273, France
  • Hopital Saint Joseph
    Marseille, 13285, France
  • CHU La Timone Marseille
    Marseille, 13385, France
  • Hôpital Nord Marseille
    Marseille, 13915, France
  • Centre Régional de Lutte Contre le Cancer Val d'Aurelle
    Montpellier, 34298, France
  • CHU Hôtel-Dieu NANTES
    Nantes, 44093, France
  • Centre de Lutte contre le Cancer (Centre René Gauducheau)
    Nantes, 44805, France
  • CHR Orleans
    Orléans, 45067, France
  • Hopital Saint Louis Paris
    Paris, 75010, France
  • Hopital Saint Antoine Paris
    Paris, 75012, France
  • Hopital de la Salpetriere Paris
    Paris, 75013, France
  • Hopital Val de GRACE
    Paris, 75230, France
  • Hôpital Kremlin Bicêtre
    Paris, 94275, France
  • CH Lyon Sud
    Pierre-Bénite, 69495, France
  • CHU Rouen
    Rouen, 76031, France
  • Centre Rene Hugunin institut curie
    Saint-Cloud, 92210, France
  • Centre Hospitalier Mutualiste Site Etienne Dolet
    Saint-Nazaire, 44 600, France
  • Clinique Charcot,
    Sainte-Foy-lès-Lyon, 69110, France
  • CHRU Strasbourg
    Strasbourg, 67091, France
  • CH Valence
    Valence, 26953, France
  • Ch Bretagne Atlantique
    Vannes, 56017, France
  • Centre Hospitalier de Villefranche sur Saône
    Villefranche-sur-Saône, 69400, France
  • Institut Gustave Roussy
    Villejuif, 94805, France
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References and documents

Publications

  • 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. PubMed 17918266 ↗
  • 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. PubMed 10499070 ↗
  • 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. PubMed 16284987 ↗
  • 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. PubMed 16460435 ↗
  • 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. PubMed 16505267 ↗
  • 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. PubMed 10737280 ↗
  • 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. PubMed 16549834 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01362933
Lead sponsor
Floralis
Collaborators
Centre Hospitalier Universitaire, Amiens, Groupe Francophone Thrombose et Cancer (GFTC), University Hospital, Grenoble
Responsible party
Sponsor
First posted
Jun 1, 2011
Start date
May 2011
Primary completion
Jan 2012
Completion
Jul 2012
Last update
Mar 6, 2015

Study contacts

Marie-Antoinette SEVESTRE, MD
principal investigator · Centre Hospitalier Universitaire, Amiens
Dominique FARGE BANCEL, MD
study director · GFTC
Jean Luc BOSSON, MD
study director · University Hospital, Grenoble

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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