Inflammatory DiseaseProteomeNCT01903642
Study of the Proteome and Cytokines During Inflammatory Syndromes of Different Etiologies.
A study testing proteomic analysis in people with Inflammatory Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The hypotheses of our research are based on the fact that various pathological states, infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through different pathways, even though the clinical presentation can be identical. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inflammatory Disease
- What is being tested?
- proteomic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Feb 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting an inflammatory syndrome, defined by elevated C-reactive protein (CRP>50mg/L), whose etiology is related to infection, cancer or an inflammatory disease.
- Patients not on treatment (corticoids, immunosuppressive drugs) during the 7 days preceding inclusion
- Age: 18-90 years
- Patients covered by the National Health Insurance Agency
- signed written informed consent form
Who cannot join
- - Any patient not meeting the inclusion criteria
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
The hypotheses of our research are based on the fact that various pathological states, infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through different pathways, even though the clinical presentation can be identical. The identification of biological markers specific to an etiology would therefore allow a faster diagnosis and improve care for patients. We thus took an interest in the three groups of diseases most frequently responsible for an inflammatory syndrome, infections, cancers and auto-immune diseases. To achieve this, various methods will be used.
- Conditions
- Inflammatory Disease
- Being tested
- proteomic analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proteomic analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with inflammatory syndrome | Other | Not described Receives: Other: proteomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of usual parameters of inflammation
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903642
- Sponsor's protocol ID
- Bonnotte PHRC IR 2008
- Acronym
- Proteome
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Proteome and Cytokines During Inflammatory Syndromes of Different Etiologies.
- ClinicalTrials.gov ID
- NCT01903642
- Acronym / sponsor ID
- Proteome / Bonnotte PHRC IR 2008
- Conditions
- Inflammatory Disease
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Jul 2013 (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 hypotheses of our research are based on the fact that various pathological states, infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through different pathways, even though the clinical presentation can be identical. The identification of biological markers specific to an etiology would therefore allow a faster diagnosis and improve care for patients. We thus took an interest in the three groups of diseases most frequently responsible for an inflammatory syndrome, infections, cancers and auto-immune diseases. To achieve this, various methods will be used.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with inflammatory syndrome | Other | Other: proteomic analysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting an inflammatory syndrome, defined by elevated C-reactive protein (CRP>50mg/L), whose etiology is related to infection, cancer or an inflammatory disease.
- Patients not on treatment (corticoids, immunosuppressive drugs) during the 7 days preceding inclusion
- Age: 18-90 years
- Patients covered by the National Health Insurance Agency
- signed written informed consent form
Key exclusion criteria (2 listed)
- - Any patient not meeting the inclusion criteria
- Pregnant patients
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 |
|---|---|---|
| proteomic analysis | Other | Patients with inflammatory syndrome |
Primary outcome
determination of usual parameters of inflammation
Time frame: at baseline
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proteomic analysis in people with Inflammatory Disease, run by Centre Hospitalier Universitaire Dijon 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Jul 2013. 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 was stopped early. Results are not available in the source record.
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?
determination of usual parameters of inflammation (time frame: at baseline). 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 19 Jul 2013.