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NeoplasmsCARMENNCT01362933

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

An observational study of Neoplasms and Venous Thromboembolism, run by Floralis at 49 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Venous Thromboembolism
What is being tested?
VTE treatment in cancer patient description
Type of treatment
Surgery or procedure
How many people
502 participants
Where
49 sitesFrance
Study dates
May 2011to Jul 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients with cancer present in the clinic, hospital, out patients diagnosed with a VTE during the 6 previous months

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

France49 sites

  • CHR Annecy

    Annecy, 74374

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95100

  • CH AUCH

    Auch, 32000

  • CH Beauvais

    Beauvais, 60021

  • Institut Bergonie

    Bordeaux, 33076

  • CHU de Brest

    Brest, 29609

  • CHU de Caen

    Caen, 14033

  • Centre François Baclesse

    Caen, 14076

  • CH Antoine Gayraud Cedex 9

    Carcassonne, 11890

  • Clinique du Parc CASTELNAU LE LEZ

    Castelnau-le-Lez, 34170

  • CH Chalons En Champagne

    Châlons-en-Champagne, 51005

  • Pôle Santé Léonard de Vinci

    Chambray-lès-Tours, 37175

  • Centre Jean Perrin Clcc

    Clermont-Ferrand, 63000

  • CHU

    Clermont-Ferrand, 63057

  • Hopital Louis Mourier Colombes

    Colombes, 92701

  • Polyclinique Saint come

    Compiègne, 60200

  • CHU Bocage Dijon

    Dijon, 21079

  • CHU

    Grenoble, 38043

  • Ch Versailles Andre Maginot

    Le Chesnay, 78157

  • CHRU Calmette

    Lille, 59037

  • CHRU LILLE, Hôpital Huriez

    Lille, 59037

  • CHRU Albert Calmette

    Lille

  • Centre Hospitalier Edouard Herriot

    Lyon, 69003

  • Hopital Desgenettes LYON

    Lyon, 69003

  • Centre Leon Berard LYON

    Lyon, 69008

  • CH Saint Joseph Saint Luc

    Lyon, 69365

  • Institut Paoli Calmette Marseille

    Marseille, 13273

  • Hopital Saint Joseph

    Marseille, 13285

  • CHU La Timone Marseille

    Marseille, 13385

  • Hôpital Nord Marseille

    Marseille, 13915

  • Centre Régional de Lutte Contre le Cancer Val d'Aurelle

    Montpellier, 34298

  • CHU Hôtel-Dieu NANTES

    Nantes, 44093

  • Centre de Lutte contre le Cancer (Centre René Gauducheau)

    Nantes, 44805

  • CHR Orleans

    Orléans, 45067

  • Hopital Saint Louis Paris

    Paris, 75010

  • Hopital Saint Antoine Paris

    Paris, 75012

  • Hopital de la Salpetriere Paris

    Paris, 75013

  • Hopital Val de GRACE

    Paris, 75230

  • Hôpital Kremlin Bicêtre

    Paris, 94275

  • CH Lyon Sud

    Pierre-Bénite, 69495

  • CHU Rouen

    Rouen, 76031

  • Centre Rene Hugunin institut curie

    Saint-Cloud, 92210

  • Centre Hospitalier Mutualiste Site Etienne Dolet

    Saint-Nazaire, 44 600

  • Clinique Charcot,

    Sainte-Foy-lès-Lyon, 69110

  • CHRU Strasbourg

    Strasbourg, 67091

  • CH Valence

    Valence, 26953

  • Ch Bretagne Atlantique

    Vannes, 56017

  • Centre Hospitalier de Villefranche sur Saône

    Villefranche-sur-Saône, 69400

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

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

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.

Being tested
VTE treatment in cancer patient description
Keywords
PE, DVT, SVT, LMWH, VKA, international Venous Thromboembolism Recommendations
Medical subject headings
Neoplasms, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VTE treatment in cancer patient descriptionProcedure or surgery

    proportion of patients treated for evolutive VTE according to international recommendations

Study groups in NCT01362933
Study groupRoleWhat they receive
VTE treatment in cancer patientAll patients with cancer present in the clinic, hospital, out patient diagnosed with a VTE during the 6 previous months.
Receives: Procedure: VTE treatment in cancer patient description

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At baseline (J0)

Secondary outcomes (4)

  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

    Measured: At baseline (J0)

  2. Proportion of asymptomatic VTE disease for this population

    percentage of VTE and cancer status (local, metastatic)

    Measured: At baseline (J0)

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

    percentage of patients practising self injections

    Measured: At baseline (J0)

  4. Proportion of patients with catheter thrombosis

    Percentage of patients receiving novel cancer therapies

    Measured: At baseline (J0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01362933
Sponsor's protocol ID
Version N°2.0 du 21/03/2011
Acronym
CARMEN
Status last verified
Mar 2015
First submitted
25 May 2011
Last updated
6 Mar 2015
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms and Venous Thromboembolism, run by Floralis at 49 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the adherence to recommendations of VTE treatment in cancer patients (time frame: At baseline (J0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01362933, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.

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