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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
    • Bretagne
      • Rennes, Bretagne, France, 35033
        • Hopital Pontchaillou
    • Centre
      • Orléans, Centre, France, 45000
        • Centre Hospitalier Régional d'Orléans
    • Hauts De France
      • Lille, Hauts De France, France, 59020
        • Centre Oscar Lambret
    • Ile De France
      • Bobigny, Ile De France, France, 93000
        • Hôpital Avicenne, Hôpitaux universitaires Paris Seine-
      • Clamart, Ile De France, France, 92140
        • Hôpital d'Instruction des Armées Percy
      • Colombes, Ile De France, France, 92700
        • Hôpital Louis Mourier
      • Créteil, Ile De France, France, 94000
        • Centre Hospitalier Intercommunal de Créteil
      • Le Chesnay, Ile De France, France, 78157
        • Centre Hospitalier de Versailles André Mignot
      • Le Kremlin Bicêtre, Ile De France, France, 94275
        • Hôpital Bicêtre
      • Paris, Ile De France, France, 75005
        • Institut Curie
      • Paris, Ile De France, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, Ile De France, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, Ile De France, France, 75013
        • Hôpital Pitié Salpêtrière
      • Paris, Ile De France, France, 75014
        • Centre Hospitalier Paris Saint-Joseph
      • Paris, Ile De France, France, 75018
        • Hopital Bichat Claude Bernard
      • Paris, Ile De France, France, 75020
        • Hôpital Tenon
      • Saint Denis, Ile De France, France, 93200
        • Centre Cardiologique du Nord
      • Suresnes, Ile De France, France, 92150
        • Hopital Foch
      • Villejuif, Ile De France, France, 94805
        • Gustave Roussy
    • Languedoc-Roussillon-Midi-Pyrénées
      • Toulouse, Languedoc-Roussillon-Midi-Pyrénées, France, 31059
        • Hopital Larrey
    • Normandie
      • Caen, Normandie, France, 14033
        • CHU de Caen
    • Nouvelle-Aquitaine
      • Poitiers, Nouvelle-Aquitaine, France, 86000
        • CHU Poitiers
    • Pays De La Loire
      • Saint Herblain, Pays De La Loire, France, 44805
        • Institut de Cancérologie de l'Ouest
    • Rhône Alpes
      • Annecy, Rhône Alpes, France, 74374
        • Centre Hospitalier Annecy Genevois
    • Rhônes Alpes
      • Lyon, Rhônes Alpes, France, 69000
        • Groupement Hospitalier Est Hospices civils de Lyon
    • Rhônes-Alpes
      • Saint Priest, Rhônes-Alpes, France, 42270
        • Institut de Cancérologie Lucien Neuwirth
    • Seine Maritime
      • Rouen, Seine Maritime, France, 76000
        • CHU de Rouen, Hôpital Charles Nicolle

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
usual care,
Experimental: Experimental
tinzaparin sodium
Drug: Tinzaparin Sodium
Subcutaneous tinzaparin 4,500 IU once daily for six months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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:

  • objectively confirmed symptomatic pulmonary embolism (PE),
  • objectively confirmed symptomatic lower-limb deep vein thrombosis (DVT) (including iliac and caval thrombosis),
  • objectively confirmed symptomatic upper extremity DVT,
  • objectively confirmed incidentally diagnosed PE or proximal DVT
  • death due to PE.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France
National Cancer Institute, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P150963
  • PHRC (French Ministry of Health)
  • 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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