Interstitial Lung DiseaseNCT02197364
The Role of KL-6 in the Clinical Diagnosis of ILD
An observational study of Interstitial Lung Disease, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases. Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 1,190 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to May 2014
- 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 14 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The serums from clinical laboratory of Shanghai Pulmonary Hospital, Nanjing Drum Tower Hospital and Beijing Chaoyang Hospital.
Who may be able to join
- Serums from patients with ILD, pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and health
- Serums from patients with ILD: before treatment and 30-90 days after treatment
Who cannot join
- Serums from patients with cancer
- Serums with visible precipitate
- Serums with floc
About this study
Official title: The Role of KL-6 as a Serum Biomarker in the Clinical Diagnosis of Interstitial Lung Diseases (ILD) in China
The purpose of the study is to evaluate the significance of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and after treatment.
Read the detailed description
As a multi-center, double-blind clinical study, the trial is divided into two parts.
Part 1: The purpose of this part is to evaluate the role of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and healthy control group.
Part 2: The purpose of this part is to study the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and 30-90 days after treatment. Treatment includes anti fibrosis, anti-inflammatory and other conventional therapies.
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial Lung Disease, Diagnosis, Krebs Von Den Lungen-6
- Medical subject headings
- Lung Diseases, Interstitial, Disease, Medullary cystic kidney disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ILD, Other respiratory diseases, Healthy control group | ILD: those with interstitial lung disease. Other respiratory diseases: those with other respiratory disease including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease. Healthy control group: those who is healthy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The KL-6 concentration on the immune analyzer
Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with ILD.
Measured: The serum from patients with ILD will be collected for the duration of hospital stay, an average of 4 weeks
Secondary outcomes (3)
The KL-6 concentration on the immune analyzer
Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease.
Measured: The serum from patients other respiratory diseases will be collected for the duration of hospital stay, an average of 4 weeks
The KL-6 concentration on the immune analyzer
Detect the KL-6 concentration in serum by the use of the immune analyzer among healthy people.
Measured: The serum from healthy people will be collected for the duration of physical examination, an average of 1 day
Change of KL-6 concentration on the immune analyzer
Change of KL-6 concentration on the immune analyzer from pretherapy to 30-90 days after treatment among patients with ILD.
Measured: pretherapy, 30-90 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Fujirebio Diagnostics, Inc.
- Responsible party
- Principal investigator, Huiping Li, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Li Hui Ping, Principal investigator, Shanghai Pulmonary Hospital , Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197364
- Sponsor's protocol ID
- KL-6_20140715
- Status last verified
- Jul 2014
- First submitted
- 16 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of KL-6 as a Serum Biomarker in the Clinical Diagnosis of Interstitial Lung Diseases (ILD) in China
- ClinicalTrials.gov ID
- NCT02197364
- Acronym / sponsor ID
- KL-6_20140715
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial Lung Disease, Diagnosis, Krebs Von Den Lungen-6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,190 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Fujirebio Diagnostics, Inc.
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Jul 2014 (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 purpose of the study is to evaluate the significance of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases. In addition, the study discusses the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and after treatment.
Detailed description
As a multi-center, double-blind clinical study, the trial is divided into two parts.
Part 1: The purpose of this part is to evaluate the role of KL-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ILD) by detecting serum KL-6 levels among patients with ILD, and comparing them to the clinical diagnostic criteria and other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and healthy control group.
Part 2: The purpose of this part is to study the value of KL-6 levels in terms of ILD treatment effect evaluation through the detection of serum KL-6 levels before treatment and 30-90 days after treatment. Treatment includes anti fibrosis, anti-inflammatory and other conventional therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILD, Other respiratory diseases, Healthy control group | – | –ILD: those with interstitial lung disease. Other respiratory diseases: those with other respiratory disease including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease. Healthy control group: those who is healthy. |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The serums from clinical laboratory of Shanghai Pulmonary Hospital, Nanjing Drum Tower Hospital and Beijing Chaoyang Hospital.
Key inclusion criteria (2 listed)
- Serums from patients with ILD, pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and health
- Serums from patients with ILD: before treatment and 30-90 days after treatment
Key exclusion criteria (3 listed)
- Serums from patients with cancer
- Serums with visible precipitate
- Serums with floc
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
The KL-6 concentration on the immune analyzer
Time frame: The serum from patients with ILD will be collected for the duration of hospital stay, an average of 4 weeks
Detect the KL-6 concentration in serum by the use of the immune analyzer among patients with ILD.
3 secondary outcomes
The KL-6 concentration on the immune analyzer
Time frame: The serum from patients other respiratory diseases will be collected for the duration of hospital stay, an average of 4 weeks
The KL-6 concentration on the immune analyzer
Time frame: The serum from healthy people will be collected for the duration of physical examination, an average of 1 day
Change of KL-6 concentration on the immune analyzer
Time frame: pretherapy, 30-90 days after treatment
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 22 Jul 2014.
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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.
Li Hui Ping principal investigator
Shanghai Pulmonary Hospital , Tongji University
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Shanghai Pulmonary Hospital, Shanghai, China.
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 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 22 Jul 2014. 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?
The KL-6 concentration on the immune analyzer (time frame: The serum from patients with ILD will be collected for the duration of hospital stay, an average of 4 weeks). 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 22 Jul 2014.