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

NCT ID: NCT01362933

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

502 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms Venous Thromboembolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

VTE treatment in cancer patient description

Intervention Type PROCEDURE

proportion of patients treated for evolutive VTE according to international recommendations

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VTE treatment in cancer patient description

proportion of patients treated for evolutive VTE according to international recommendations

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role collaborator

Groupe Francophone Thrombose et Cancer (GFTC)

UNKNOWN

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

Floralis

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marie-Antoinette SEVESTRE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire, Amiens

Dominique FARGE BANCEL, MD

Role: STUDY_DIRECTOR

GFTC

Jean Luc BOSSON, MD

Role: STUDY_DIRECTOR

University Hospital, Grenoble

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHR Annecy

Annecy, , France

Site Status

Centre Hospitalier Victor Dupouy

Argenteuil, , France

Site Status

CH AUCH

Auch, , France

Site Status

CH Beauvais

Beauvais, , France

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

CHU de Brest

Brest, , France

Site Status

CHU de Caen

Caen, , France

Site Status

Centre François Baclesse

Caen, , France

Site Status

CH Antoine Gayraud Cedex 9

Carcassonne, , France

Site Status

Clinique du Parc CASTELNAU LE LEZ

Castelnau-le-Lez, , France

Site Status

Pôle Santé Léonard de Vinci

Chambray-lès-Tours, , France

Site Status

CH Chalons En Champagne

Châlons-en-Champagne, , France

Site Status

Centre Jean Perrin Clcc

Clermont-Ferrand, , France

Site Status

CHU

Clermont-Ferrand, , France

Site Status

Hopital Louis Mourier Colombes

Colombes, , France

Site Status

Polyclinique Saint come

Compiègne, , France

Site Status

CHU Bocage Dijon

Dijon, , France

Site Status

CHU

Grenoble, , France

Site Status

Ch Versailles Andre Maginot

Le Chesnay, , France

Site Status

CHRU Calmette

Lille, , France

Site Status

CHRU LILLE, Hôpital Huriez

Lille, , France

Site Status

CHRU Albert Calmette

Lille, , France

Site Status

Centre Hospitalier Edouard Herriot

Lyon, , France

Site Status

Hopital Desgenettes LYON

Lyon, , France

Site Status

Centre Leon Berard LYON

Lyon, , France

Site Status

CH Saint Joseph Saint Luc

Lyon, , France

Site Status

Institut Paoli Calmette Marseille

Marseille, , France

Site Status

Hopital Saint Joseph

Marseille, , France

Site Status

CHU La Timone Marseille

Marseille, , France

Site Status

Hôpital Nord Marseille

Marseille, , France

Site Status

Centre Régional de Lutte Contre le Cancer Val d'Aurelle

Montpellier, , France

Site Status

CHU Hôtel-Dieu NANTES

Nantes, , France

Site Status

Centre de Lutte contre le Cancer (Centre René Gauducheau)

Nantes, , France

Site Status

CHR Orleans

Orléans, , France

Site Status

Hopital Saint Louis Paris

Paris, , France

Site Status

Hopital Saint Antoine Paris

Paris, , France

Site Status

Hopital de la Salpetriere Paris

Paris, , France

Site Status

Hopital Val de GRACE

Paris, , France

Site Status

Hôpital Kremlin Bicêtre

Paris, , France

Site Status

CH Lyon Sud

Pierre-Bénite, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

Centre Rene Hugunin institut curie

Saint-Cloud, , France

Site Status

Centre Hospitalier Mutualiste Site Etienne Dolet

Saint-Nazaire, , France

Site Status

Clinique Charcot,

Sainte-Foy-lès-Lyon, , France

Site Status

CHRU Strasbourg

Strasbourg, , France

Site Status

CH Valence

Valence, , France

Site Status

Ch Bretagne Atlantique

Vannes, , France

Site Status

Centre Hospitalier de Villefranche sur Saône

Villefranche-sur-Saône, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17918266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10499070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16284987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16460435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16505267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10737280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16549834 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ncbi.nlm.nih.gov/pubmed/17968019

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Version N°2.0 du 21/03/2011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Allo - Cancer - Thrombosis
NCT03563924 UNKNOWN