Evaluation of Predictive Proteic Profile on Mortality in... | NCT00930085

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

NCT00930085

Sponsor

Institut Paoli-Calmettes

Status

Completed

Last Update Posted

Sep 14, 2011Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Sepsis
Septic Shock
Cancer

Interventions

SELDI-TOF MS for plasmatic proteic profile

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Apr 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jun 22, 2009

First Submission Date that Met QC Criteria

Jun 27, 2009

First Posted Date

Jun 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2011

Last Update Posted Date

Sep 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SELDI-TOF MS	Experimental	The proteic profiling is performed by SELDI-TOF mass spectroscopy.	Other: SELDI-TOF MS for plasmatic proteic profile

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SELDI-TOF MS for plasmatic proteic profile	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).

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Djamel MOKART, MD	Institut Paoli-Calmettes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Paoli-Calmettes		Marseille			France

Label	URL
official web site of the sponsor	View source

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic
D009369	Neoplasms

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019032	Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

Ancestor Terms

ID	Term
D013058	Mass Spectrometry
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided