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NCT00930085 Clinical Trial

Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients

Cancer Clinical Trial

— PROTEOHSEPS  

Official title:
Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00930085
Other study ID # PROTEOHSEPS/IPC 2005-011
Secondary ID
Status Completed
Phase N/A
First received June 22, 2009
Last updated September 13, 2011
Start date August 2008
Est. completion date May 2011

Study information
Verified date September 2011
Source Institut Paoli-Calmettes
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The mortality induced by infections in onco-hematological patients is abnormally high at the acute phase of septic shock. Consequently, it is important to detect the population with a high risk of short term mortality among patients with a septic shock. The aim of this study is the evaluation of predictive proteic profile on the short term mortality in the acute phase of septic shock in cancer patients.

Description:

Method: Monocentric prospective study with diagnostic and prognostic expectations.

Primary objective:

Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock.

Secondary objective:

Research of clinical and biological prognostic factors.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient from oncology or hematology with a septic shock

- Patient aged 18 years and older

- Inclusion within the 24 hours of the septic shock in the intensive care unit

- Signed consent according to the emergency reglementation

Exclusion Criteria:

- Pregnancy, breast feeding

- Patient with decision of care limitation

- Patient with legal protection

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• SELDI-TOF MS for plasmatic proteic profile
An extra blood sample is required to determine the plasmatic proteic profile used to identify one or several signatures which are correlated to the clinical evolution (mortality at D30).

Locations
Country Name City State
France Institut Paoli-Calmettes Marseille

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock. 1 month No
Secondary Research of clinical and biological prognostic factors. 1 month No
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