BiomarkersNCT03282383
Identification of Biomarkers for Severe Pneumonia
An observational study of Biomarkers, run by Changhai Hospital.
Trial summary
To identify the potential serum biomarkers with regard to the severity of pneumonia, and to further evaluate the prognostic value of these markers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biomarkers
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Dec 2016
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: collection the blood from 600 patients
Who may be able to join
- under 18 years old
Who cannot join
- over 80 years old
About this study
Official title: Shanghai Changhai Hospital,Second Military Medical University
To identify the potential serum biomarkers with regard to the severity of pneumonia, and to further evaluate the prognostic value of these markers.
Read the detailed description
First, we will collect serum samples from patients with pneumonia. Then we will identify biomarkers differentially expressed between non-severe pneumonia and severe pneumonia. We will further evaluate the prognostic value of these markers for pneumonia.
- Conditions
- Biomarkers
- Keywords
- biomarkers pneumonia severity
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA
the all of microRNA of blood plasma
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Jan 2014
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangyu Kong, Changhai Hospital
- Investigators
- Xiangyu Kong, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282383
- Sponsor's protocol ID
- Severe pneumonia biomarkers
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Changhai Hospital,Second Military Medical University
- ClinicalTrials.gov ID
- NCT03282383
- Acronym / sponsor ID
- Severe pneumonia biomarkers
- Conditions
- Biomarkers
- Keywords
- biomarkers pneumonia severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 13 Sep 2017 (actual)
- 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.
To identify the potential serum biomarkers with regard to the severity of pneumonia, and to further evaluate the prognostic value of these markers.
Detailed description
First, we will collect serum samples from patients with pneumonia. Then we will identify biomarkers differentially expressed between non-severe pneumonia and severe pneumonia. We will further evaluate the prognostic value of these markers for pneumonia.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- collection the blood from 600 patients
Key inclusion criteria (1 listed)
- under 18 years old
Key exclusion criteria (1 listed)
- over 80 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
microRNA
Time frame: 3 years
the all of microRNA of blood plasma
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 13 Sep 2017.
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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.
Xiangyu Kong, MD principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers, run by Changhai Hospital.
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 1 inclusion and 1 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
microRNA (time frame: 3 years). 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 13 Sep 2017.