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

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ClinicalTrials.gov Identifier: NCT00930085
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : September 14, 2011
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief 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.

Condition or disease Intervention/treatment
Sepsis Septic Shock Cancer Other: SELDI-TOF MS for plasmatic proteic profile

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients
Study Start Date : August 2008
Primary Completion Date : April 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SELDI-TOF MS
The proteic profiling is performed by SELDI-TOF mass spectroscopy.
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).



Primary Outcome Measures :
  1. Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Research of clinical and biological prognostic factors. [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00930085


Locations
France
Institut Paoli-Calmettes
Marseille, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Djamel MOKART, MD Institut Paoli-Calmettes

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00930085     History of Changes
Other Study ID Numbers: PROTEOHSEPS/IPC 2005-011
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by Institut Paoli-Calmettes:
sepsis
septic shock

Additional relevant MeSH terms:
Sepsis
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes