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

NCT ID: NCT00930085

Last Updated: 2011-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sepsis Septic Shock Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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SELDI-TOF MS

The proteic profiling is performed by SELDI-TOF mass spectroscopy.

Group Type EXPERIMENTAL

SELDI-TOF MS for plasmatic proteic profile

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Djamel MOKART, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Institut Paoli-Calmettes

Marseille, , France

Site Status

Countries

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France

Related Links

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http://www.institutpaolicalmettes.fr

official web site of the sponsor

Other Identifiers

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PROTEOHSEPS/IPC 2005-011

Identifier Type: -

Identifier Source: org_study_id

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