ProcalcitoninNCT03350802
Procalcitonin Test for Differentiation of the Cause of Pneumonia
An observational study of Procalcitonin and Pneumonia, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the usefulness of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procalcitonin, Pneumonia, Cancer
- What is being tested?
- procalcitonin test
- How many people
- 649 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2014to 30 Jun 2020
- 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
Study population: 1. Patients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort. * suspected symptom: cough, sputum, dyspnea or fever/chill * suspected image findings: consolidation or ground-glass opacity on chest radiograph or CT 2. All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test. * basic microbiological test: blood culture, sputum gram stain/culture, pneumococcal urinary antigen, legionella urinary antigen, mycoplasma antibody etc.
Who may be able to join
- Age greater than 18 years
- Patients who have symptoms and suspected imaging findings compatible with pneumonia
Who cannot join
- Patients who have been treated with antibiotics or steroid therapy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Respiratory Clinic, National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Usefulness of Procalcitonin Test to Differentiate the Cause of Pneumonia in Patients With Cancers
The purpose of this study is to evaluate the usefulness of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.
Read the detailed description
Serum procalcitonin test is currently used as the biomarker for bacterial infection. Especially, procalcitonin test has been reported to be helpful in differentiating bacterial pneumonia from viral pneumonia, acute exacerbations of interstitial pneumonitis or chronic obstructive lung disease. However, it is not known whether procalcitonin test can help distinguish bacterial pneumonia from non-bacterial pneumonia such as radiation pneumonitis or chemotherapy-induced pneumonitis in patients with cancer.
The aim of this prospective cohort study is to observe the clinical benefits of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.
- Conditions
- Procalcitonin, Pneumonia, Cancer
- Being tested
- procalcitonin test
- Medical subject headings
- Pneumonia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitonin testDiagnostic test
All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test.
| Study group | Role | What they receive |
|---|---|---|
| procalcitonin pneumonia cohort | Patients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort. Receives: Diagnostic Test: procalcitonin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procalcitonin level according to the cause of pneumonia in patients with cancer
bacterial pneumonia vs. radiation pneumonitis vs chemotherapy-induced pneumonitis
Measured: procalcitonin level is checked within 24hours after visiting hospital
Secondary outcomes (2)
Influence of neutropenia on procalcitonin level in patients with baterial pneumonia
bacterial pneumonia with neutropenia vs. without neutropenia
Measured: procalcitonin level is checked within 24hours after visiting hospital
procalcitonin level in patients with atypical pneumonia
viral pneumonia vs tuberculosis vs fungal infection
Measured: procalcitonin level is checked within 24hours after visiting hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Jan 2014
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProcalcitoninStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 649 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hee Seok Lee, National Cancer Center, Korea
- Investigators
- HEE SEOK LEE, M.D., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350802
- Sponsor's protocol ID
- NCC2014-0018
- Status last verified
- Sep 2020
- First submitted
- 17 Nov 2017
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Procalcitonin Test to Differentiate the Cause of Pneumonia in Patients With Cancers
- ClinicalTrials.gov ID
- NCT03350802
- Acronym / sponsor ID
- NCC2014-0018
- Conditions
- Procalcitonin, Pneumonia, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Nov 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.
The purpose of this study is to evaluate the usefulness of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.
Detailed description
Serum procalcitonin test is currently used as the biomarker for bacterial infection. Especially, procalcitonin test has been reported to be helpful in differentiating bacterial pneumonia from viral pneumonia, acute exacerbations of interstitial pneumonitis or chronic obstructive lung disease. However, it is not known whether procalcitonin test can help distinguish bacterial pneumonia from non-bacterial pneumonia such as radiation pneumonitis or chemotherapy-induced pneumonitis in patients with cancer.
The aim of this prospective cohort study is to observe the clinical benefits of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| procalcitonin pneumonia cohort | – | Diagnostic Test: procalcitonin testPatients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort. * suspected symptom: cough, sputum, dyspnea or fever/chill * suspected image findings: consolidation or ground-glass opacity on chest radiograph or CT 2. All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test. * basic microbiological test: blood culture, sputum gram stain/culture, pneumococcal urinary antigen, legionella urinary antigen, mycoplasma antibody etc.
Key inclusion criteria (2 listed)
- Age greater than 18 years
- Patients who have symptoms and suspected imaging findings compatible with pneumonia
Key exclusion criteria (1 listed)
- Patients who have been treated with antibiotics or steroid therapy.
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 |
|---|---|---|
| procalcitonin testAll patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test. | Diagnostic test | procalcitonin pneumonia cohort |
Primary outcome
Procalcitonin level according to the cause of pneumonia in patients with cancer
Time frame: procalcitonin level is checked within 24hours after visiting hospital
bacterial pneumonia vs. radiation pneumonitis vs chemotherapy-induced pneumonitis
2 secondary outcomes
Influence of neutropenia on procalcitonin level in patients with baterial pneumonia
Time frame: procalcitonin level is checked within 24hours after visiting hospital
procalcitonin level in patients with atypical pneumonia
Time frame: procalcitonin level is checked within 24hours after visiting hospital
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 25 Sep 2020.
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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.
HEE SEOK LEE, M.D. principal investigator
National Cancer Center
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 Procalcitonin and Pneumonia, run by National Cancer Center, Korea at 1 site in South Korea.
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 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 25 Sep 2020. 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 South Korea. 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?
Procalcitonin level according to the cause of pneumonia in patients with cancer (time frame: procalcitonin level is checked within 24hours after visiting hospital). 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 25 Sep 2020.