SepsisPROTEOHSEPSNCT00930085
Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients
A study testing SELDI-TOF MS for plasmatic proteic profile in people with Sepsis and Septic Shock, run by Institut Paoli-Calmettes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Cancer
- What is being tested?
- SELDI-TOF MS for plasmatic proteic profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2008to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy, breast feeding
- Patient with decision of care limitation
- Patient with legal protection
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sepsis, Septic Shock, Cancer
- Being tested
- SELDI-TOF MS for plasmatic proteic profile
- Keywords
- sepsis, septic shock
- Medical subject headings
- Sepsis, Shock, Septic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| SELDI-TOF MS | Experimental | The proteic profiling is performed by SELDI-TOF mass spectroscopy. Receives: Other: SELDI-TOF MS for plasmatic proteic profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock.
Measured: 1 month
Secondary outcomes (1)
Research of clinical and biological prognostic factors.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Djamel MOKART, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930085
- Sponsor's protocol ID
- PROTEOHSEPS/IPC 2005-011
- Acronym
- PROTEOHSEPS
- Status last verified
- Sep 2011
- First submitted
- 22 Jun 2009
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients
- ClinicalTrials.gov ID
- NCT00930085
- Acronym / sponsor ID
- PROTEOHSEPS / PROTEOHSEPS/IPC 2005-011
- Conditions
- Sepsis, Septic Shock, Cancer
- Keywords
- sepsis, septic shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SELDI-TOF MS | Experimental | Other: SELDI-TOF MS for plasmatic proteic profileThe proteic profiling is performed by SELDI-TOF mass spectroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy, breast feeding
- Patient with decision of care limitation
- Patient with legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SELDI-TOF MS for plasmatic proteic profileAn 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). | Other | SELDI-TOF MS |
Primary outcome
Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock.
Time frame: 1 month
1 secondary outcome
Research of clinical and biological prognostic factors.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
- official web site of the sponsorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djamel MOKART, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SELDI-TOF MS for plasmatic proteic profile in people with Sepsis and Septic Shock, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2011.