- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03090880
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE) (PROVE)
November 14, 2022 updated by: Assistance Publique - Hôpitaux de Paris
Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bretagne
-
Rennes, Bretagne, France, 35033
- Hôpital Pontchaillou
-
-
Centre
-
Orléans, Centre, France, 45000
- Centre Hospitalier Régional D'orléans
-
-
Hauts De France
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Lille, Hauts De France, France, 59020
- Centre Oscar Lambret
-
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Ile De France
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Bobigny, Ile De France, France, 93000
- Hôpital Avicenne, Hôpitaux universitaires Paris Seine-
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Clamart, Ile De France, France, 92140
- Hôpital d'Instruction des Armées PERCY
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Colombes, Ile De France, France, 92700
- Hôpital Louis Mourier
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Créteil, Ile De France, France, 94000
- Centre Hospitalier Intercommunal de Créteil
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Le Chesnay, Ile De France, France, 78157
- Centre Hospitalier de Versailles André Mignot
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Le Kremlin Bicêtre, Ile De France, France, 94275
- Hopital Bicetre
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Paris, Ile De France, France, 75005
- Institut Curie
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Paris, Ile De France, France, 75014
- Institut Mutualiste Montsouris
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Paris, Ile De France, France, 75015
- Hopital Europeen Georges Pompidou
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Paris, Ile De France, France, 75013
- Hopital Pitié Salpetriere
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Paris, Ile De France, France, 75014
- Centre Hospitalier Paris Saint-Joseph
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Paris, Ile De France, France, 75018
- Hopital Bichat Claude Bernard
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Paris, Ile De France, France, 75020
- Hopital Tenon
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Saint Denis, Ile De France, France, 93200
- Centre Cardiologique du Nord
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Suresnes, Ile De France, France, 92150
- Hopital Foch
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Villejuif, Ile De France, France, 94805
- Gustave Roussy
-
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Languedoc-Roussillon-Midi-Pyrénées
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Toulouse, Languedoc-Roussillon-Midi-Pyrénées, France, 31059
- Hopital Larrey
-
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Normandie
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Caen, Normandie, France, 14033
- CHU de Caen
-
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Nouvelle-Aquitaine
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Poitiers, Nouvelle-Aquitaine, France, 86000
- CHU Poitiers
-
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Pays De La Loire
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Saint Herblain, Pays De La Loire, France, 44805
- Institut de Cancérologie de l'Ouest
-
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Rhône Alpes
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Annecy, Rhône Alpes, France, 74374
- Centre Hospitalier Annecy Genevois
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Rhônes Alpes
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Lyon, Rhônes Alpes, France, 69000
- Groupement Hospitalier Est Hospices civils de Lyon
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Rhônes-Alpes
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Saint Priest, Rhônes-Alpes, France, 42270
- Institut de Cancérologie Lucien Neuwirth
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Seine Maritime
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Rouen, Seine Maritime, France, 76000
- CHU de Rouen, Hopital Charles Nicolle
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years
- Social security affiliation
- Written informed consent
- Histologically confirmed stage IV (M1a or M1b) non-small-cell lung cancer, including recurrent non-small-cell lung cancer after a period of complete remission
- D-dimer > 1,500 µg/L
- First line of systemic cancer treatment (chemotherapy, immunotherapy or targeted therapy), or new line of systemic cancer treatment for cancer progression (chemotherapy, immunotherapy or targeted therapy), introduced during the month preceding inclusion or planned within one month after inclusion
- ECOG (Eastern Cooperative Oncology Group) score 0-2
- Life expectancy >3 months
Exclusion Criteria:
- Hypersensitivity to heparin or to any excipients
- Septic endocarditis
- History of heparin-induced thrombocytopenia
- Ongoing anticoagulant treatment at therapeutic dosage
- VTE at inclusion
- Creatinin clearance <30 mL/min
- Active bleeding
- Platelet count < 100 G/L at inclusion
- Severe hepatic insufficiency
- Cancer treated exclusively with supportive care
- Aspirin at daily dosage > 160 mg
- Pregnancy
- Patient under tutorship or curatorship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
usual care,
|
|
Experimental: Experimental
tinzaparin sodium
|
Subcutaneous tinzaparin 4,500 IU once daily for six months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
venous thromboembolic events
Time Frame: 6 months
|
All venous thromboembolism (VTE) events during the six-month treatment period including:
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptomatic VTE events
Time Frame: 6 months
|
Objectively confirmed symptomatic VTE and death due to PE
|
6 months
|
Venous thromboembolic events
Time Frame: 12 months
|
Objectively confirmed symptomatic or incidental VTE during the 12-months study period
|
12 months
|
Major bleedings
Time Frame: 6 months
|
Major bleeding according to the ISTH criteria
|
6 months
|
Death
Time Frame: 6 months
|
Overall mortality and causes of death
|
6 months
|
Death
Time Frame: 12 months
|
Overall mortality and causes of death
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk factors for venous thromboembolism
Time Frame: 12 months
|
Risk factors for venous thromboembolism
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Guy Meyer, MD, Assistance Publique - Hôpitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2018
Primary Completion (Actual)
August 18, 2021
Study Completion (Actual)
August 18, 2021
Study Registration Dates
First Submitted
March 21, 2017
First Submitted That Met QC Criteria
March 21, 2017
First Posted (Actual)
March 27, 2017
Study Record Updates
Last Update Posted (Actual)
November 17, 2022
Last Update Submitted That Met QC Criteria
November 14, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Embolism and Thrombosis
- Lung Neoplasms
- Thromboembolism
- Venous Thromboembolism
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
Other Study ID Numbers
- P150963
- PHRC (2001/1939)
- 2016-002546-23 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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