NCT00930085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable sepsis

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

2.7 years

First QC Date

June 22, 2009

Last Update Submit

September 13, 2011

Conditions

SepsisSeptic ShockCancer

Keywords

sepsisseptic shock

Outcome Measures

Primary Outcomes (1)

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

    1 month

Secondary Outcomes (1)

  • Research of clinical and biological prognostic factors.

    1 month

Study Arms (1)

SELDI-TOF MS

EXPERIMENTAL

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

Other: SELDI-TOF MS for plasmatic proteic profile

Interventions

SELDI-TOF MS for plasmatic proteic profileOTHER

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).

SELDI-TOF MS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient from oncology or hematology with a septic shock
  • Patient aged 18 years and older
  • Signed consent according to the emergency reglementation

You may not qualify if:

  • Pregnancy, breast feeding
  • Patient with decision of care limitation
  • Patient with legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli-Calmettes

Marseille, France

Location

Related Links

MeSH Terms

Conditions

SepsisShock, SepticNeoplasms

Interventions

Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Mass SpectrometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Djamel MOKART, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 30, 2009

Study Start

August 1, 2008

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations

FR(1)