Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025894
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

Brief Summary:
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.

Condition or disease
Cancer

Layout table for study information
Study Type : Observational
Actual Enrollment : 3032 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study
Actual Study Start Date : June 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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



Primary Outcome Measures :
  1. Thromboembolic complications: [ Time Frame: one year ]
  2. Locoregional or disseminated infectious complications: [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Medical and economic consequences of these complications [ Time Frame: one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cohort of consecutive patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025894


Locations
Layout table for location information
France
CH d'Annecy
Annecy, France
CH Intercommunal Annemasse-Bonneville
Annemasse, France
Polyclinique de Savoie
Annemasse, France
CH Chambéry
Chambéry, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Pôle Santé république
Clermont-Ferrand, France
CH Feurs
Feurs, France
Institut Daniel Hollard
Grenoble, France
CH EmileRoux
Le Puy en Velay, France
CH Lyon Sud
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 de la Croix Rousse
Lyon, France
Hôpital Desgenettes
Lyon, France
Hôpital privé Jean-Mermoz
Lyon, France
Infirmerie Protestante
Lyon, France
CH de Montbrison
Montbrison, France
CH de Roanne
Roanne, France
Institut Cancérologique Lucien neuwirth
Saint Priest en Jarez, France
CH Pays du Gier
Saint-Chamond, France
CHU Saint-Etienne Service de Gynécologie
Saint-Etienne, France, 42055
CHU Saint-Etienne Service de Gastroentérologie
Saint-Etienne, France
Hôpital privé de la Loire
Saint-Etienne, France
Hôpitaux du Léman
Thonon-les-bains, France
Hôpital Privé Drôme Ardèche
Valence, France
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
Layout table for investigator information
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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT02025894     History of Changes
Other Study ID Numbers: 2010-01
2010-A01064-35 ( Other Identifier: French ministry of health )
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: December 2013
Keywords provided by Institut de Cancérologie de la Loire:
neoplastic solid tumour
PCVC
thromboembolic complications
infectious complications
risk factors
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection