Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study (ONCOCIP)

March 6, 2017 updated by: Institut de Cancérologie de la Loire
The purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). A better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3032

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
      • Annecy, France
        • CH d'Annecy
      • Annemasse, France
        • CH Intercommunal Annemasse-Bonneville
      • Annemasse, France
        • Polyclinique de Savoie
      • Chambéry, France
        • CH Chambery
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand
      • Clermont-Ferrand, France
        • Pôle Santé République
      • Feurs, France
        • CH Feurs
      • Grenoble, France
        • Institut Daniel Hollard
      • Le Puy en Velay, France
        • CH EmileRoux
      • Lyon, France
        • Hopital de La Croix Rousse
      • Lyon, France
        • CH Lyon sud
      • Lyon, France
        • Infirmerie Protestante
      • Lyon, France
        • Clinique de la sauvergarde
      • Lyon, France
        • Clinique Eugène André
      • Lyon, France
        • Clinique Portes du Sud
      • Lyon, France
        • Clinique Saint-Joseph Saint-Luc
      • Lyon, France
        • Hôpital Desgenettes
      • Lyon, France
        • Hôpital privé Jean-Mermoz
      • Montbrison, France
        • CH de MONTBRISON
      • Roanne, France
        • CH de Roanne
      • Saint Priest en Jarez, France
        • Institut Cancérologique Lucien neuwirth
      • Saint-Chamond, France
        • CH Pays du Gier
      • Saint-Etienne, France
        • Hôpital privé de la Loire
      • Saint-Etienne, France, 42055
        • CHU Saint-Etienne Service de Gynécologie
      • Saint-Etienne, France
        • CHU Saint-Etienne Service de Gastroentérologie
      • Thonon-les-bains, France
        • Hôpitaux du Léman
      • Valence, France
        • Hôpital Privé Drôme Ardèche

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

Sampling Method

Non-Probability Sample

Study Population

cohort of consecutive patients

Description

Inclusion Criteria:

  • Patient with a neoplastic solid tumour with an indication for insertion of a PCVC.

Exclusion Criteria:

  • Haematological neoplasm pathology, PCVC removal scheduled within 2 weeks of insertion,
  • Therapeutic doses of anticoagulants required at inclusion,
  • PCVC inserted by the femoral vein

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

Cohorts and Interventions

Group / Cohort
PCVCs
Cohort of cancer patients with indication PCVC under the usual practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thromboembolic complications:
Time Frame: one year
one year
Locoregional or disseminated infectious complications:
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Medical and economic consequences of these complications
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de la Loire

Investigators

  • Principal Investigator: Pierre Fournel, MD, Institut Cancérologique Lucien neuwirth
  • Study Director: Hervé DECOUSUS, MDPhD, CIC - CHU DE SAINT-ETIENNE
  • Study Director: Franck CHAUVIN, MDPhD, Institut Cancérologique Lucien neuwirth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 31, 2013

First Submitted That Met QC Criteria

December 31, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-01 (internal number)
  • 2010-A01064-35 (Other Identifier: French ministry of health)

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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