Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT00930085
First received: June 22, 2009
Last updated: September 13, 2011
Last verified: September 2011

June 22, 2009
September 13, 2011
August 2008
April 2011   (final data collection date for primary outcome measure)
Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00930085 on ClinicalTrials.gov Archive Site
Research of clinical and biological prognostic factors. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients
Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Sepsis
  • Septic Shock
  • Cancer
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).
Experimental: SELDI-TOF MS
The proteic profiling is performed by SELDI-TOF mass spectroscopy.
Intervention: Other: SELDI-TOF MS for plasmatic proteic profile
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00930085
PROTEOHSEPS/IPC 2005-011
No
Institut Paoli-Calmettes
Institut Paoli-Calmettes
Not Provided
Principal Investigator: Djamel MOKART, MD Institut Paoli-Calmettes
Institut Paoli-Calmettes
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP