Spots Global Cancer Trial Database for Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)
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Trial Identification
Brief Title: Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)
Official Title: Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer
Study ID: NCT03090880
Interventions
Study Description
Brief Summary: Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.
Detailed Description: Adult patients aged ≥ 18 years with stage IV lung cancer and elevated D-dimer will be randomized to the experimental or control group.Patients in the control group will receive usual care, patients in the experimental group will receive subcutaneous tinzaparin once daily for six months. Follow-up visit will take place in outpatient clinic at day 90, day 180 and day 360. Blood sampling for biomarkers will be performed at inclusion visit and day 90.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hôpital Pontchaillou, Rennes, Bretagne, France
Centre Hospitalier régional d'Orléans, Orléans, Centre, France
Centre Oscar Lambret, Lille, Hauts De France, France
Hôpital Avicenne, Hôpitaux universitaires Paris Seine-, Bobigny, Ile De France, France
Hôpital d'Instruction des Armées Percy, Clamart, Ile De France, France
Hôpital Louis Mourier, Colombes, Ile De France, France
Centre Hospitalier Intercommunal de Créteil, Créteil, Ile De France, France
Centre Hospitalier de Versailles André Mignot, Le Chesnay, Ile De France, France
Hôpital Bicêtre, Le Kremlin Bicêtre, Ile De France, France
Institut Curie, Paris, Ile De France, France
Hôpital Pitié Salpétrière, Paris, Ile De France, France
Centre Hospitalier Paris Saint-Joseph, Paris, Ile De France, France
Institut Mutualiste Montsouris, Paris, Ile De France, France
Hôpital Européen Georges Pompidou, Paris, Ile De France, France
Hôpital Bichat Claude Bernard, Paris, Ile De France, France
Hôpital Tenon, Paris, Ile De France, France
Centre cardiologique du Nord, Saint Denis, Ile De France, France
Hôpital Foch, Suresnes, Ile De France, France
Gustave Roussy, Villejuif, Ile De France, France
Hôpital Larrey, Toulouse, Languedoc-Roussillon-Midi-Pyrénées, France
CHU de Caen, Caen, Normandie, France
CHU Poitiers, Poitiers, Nouvelle-Aquitaine, France
Institut de cancérologie de l'Ouest, Saint Herblain, Pays De La Loire, France
Centre Hospitalier Annecy Genevois, Annecy, Rhône Alpes, France
Groupement Hospitalier Est Hospices civils de Lyon, Lyon, Rhônes Alpes, France
Institut de Cancérologie Lucien Neuwirth, Saint Priest, Rhônes-Alpes, France
CHU de Rouen, Hôpital Charles Nicolle, Rouen, Seine Maritime, France
Contact Details
Name: Guy Meyer, MD
Affiliation: Assistance Publique - Hôpitaux de Paris
Role: PRINCIPAL_INVESTIGATOR
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