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

September 13, 2011 updated by: Institut Paoli-Calmettes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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
      • Marseille, France
        • Institut Paoli-Calmettes

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

Description

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 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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Research of clinical and biological prognostic factors.
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Djamel MOKART, MD, Institut Paoli-Calmettes

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.

Helpful Links

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

August 1, 2008

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 27, 2009

First Posted (ESTIMATE)

June 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2011

Last Update Submitted That Met QC Criteria

September 13, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROTEOHSEPS/IPC 2005-011

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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