Pleural EffusionNCT00172835
Use of Procalcitonin in the Diagnosis of Pleural Effusion
An observational study of Pleural Effusion, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Among several markers of inflammation and sepsis, procalcitonin (PCT) markers is being studied to investigate their accuracy for the diagnosis of bacterial infections. PCT is the prehormone of calcitonin, which is normally secreted by the C cells of the thyroid in response to hypercalcemia; under these normal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2005to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of pleural effusion
- Pleural effusion proved by chest sonography
Who cannot join
- Conditions for which thoracentesis are contraindicated
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Po-Ren Hsueh, MD, 776-2-23565363, prhsueh@ntumc.org
About this study
Official title: Evaluation of Procalcitonin as a Diagnostic Tool for Patients With Pleural Effusion
Among several markers of inflammation and sepsis, procalcitonin (PCT) markers is being studied to investigate their accuracy for the diagnosis of bacterial infections. PCT is the prehormone of calcitonin, which is normally secreted by the C cells of the thyroid in response to hypercalcemia; under these normal conditions, negligible serumPCT concentrations are detected. The mechanism proposed for PCT production after inflammation and its role are still not completely known. It is believed that PCT is produced by the liver and peripheral blood mononuclear cells, modulated by lipopolysaccharides and sepsis-related cytokines. It binds to polysaccharides in pathogens, activating the classical complement pathway. The reported diagnostic accuracy of PCT for the diagnosis of bacterial infections has varied across studies.
- Conditions
- Pleural Effusion
- Keywords
- pleural effusion, procalcitonin
- Medical subject headings
- Pleural Effusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Natural history
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Po-Ren Hsueh, MD, Principal investigator, Department of Laboratory Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172835
- Sponsor's protocol ID
- 9461700208
- Status last verified
- Mar 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Procalcitonin as a Diagnostic Tool for Patients With Pleural Effusion
- ClinicalTrials.gov ID
- NCT00172835
- Acronym / sponsor ID
- 9461700208
- Conditions
- Pleural Effusion
- Keywords
- pleural effusion, procalcitonin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2005
- First posted
- 15 Sep 2005 (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.
Among several markers of inflammation and sepsis, procalcitonin (PCT) markers is being studied to investigate their accuracy for the diagnosis of bacterial infections. PCT is the prehormone of calcitonin, which is normally secreted by the C cells of the thyroid in response to hypercalcemia; under these normal conditions, negligible serumPCT concentrations are detected. The mechanism proposed for PCT production after inflammation and its role are still not completely known. It is believed that PCT is produced by the liver and peripheral blood mononuclear cells, modulated by lipopolysaccharides and sepsis-related cytokines. It binds to polysaccharides in pathogens, activating the classical complement pathway. The reported diagnostic accuracy of PCT for the diagnosis of bacterial infections has varied across studies.
Study design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of pleural effusion
- Pleural effusion proved by chest sonography
Key exclusion criteria (2 listed)
- Conditions for which thoracentesis are contraindicated
- Pregnancy
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Po-Ren Hsueh, MD principal investigator
Department of Laboratory Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po-Ren Hsueh, MD (886-2-2356-5363, prhsueh@ntumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Sep 2005.