Interstitial Lung Disease, DesquamativeNCT02960672
Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease
An observational study of Interstitial Lung Disease, Desquamative, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly variable clinical process.thence it is significant for the patient to search a convenient and accurate prediction method. The objective of this study was to determine whether peripheral blood biomarkers can predict disease . Read more about this study
- Who is it for?
- Ages 40 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease, Desquamative
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Dec 2018
- 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 40 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects with a diagnosis of idiopathic interstitial pneumonias made in accordance with the American Thoracic Society (ATS)/European Respiratory Society (ERS) consensus classification
Who may be able to join
- Clinical diagnosis of interstitial lung disease
Who cannot join
- Diagnosise of interstitial lung disease acute excerbation
- Combined pulmonary embolism, pulmonary edema, pulmonary tuberculosis, and peumonias
Trial locations and contacts
1 site in 1 country.
About this study
Interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly variable clinical process.thence it is significant for the patient to search a convenient and accurate prediction method. The objective of this study was to determine whether peripheral blood biomarkers can predict disease .
Read the detailed description
The median follow-up period was 12 months, each patient received 4 or 5 follow-ups in our center, 336 person-times in study enrollment totally. The patients with interstitial lung disease had significantly higher serum baseline KL-6 and MMP-7 levels compared with healthy control.They divided into progressive group and non-progressive group according to disease change. Serum KL-6 and MMP-7 levels were elevated in patients if disease progression, but baseline level of biomarkers in progressive group were not significant higher compare with non-progressive group .Binary logistic regression showed △KL-6 and △MMP-7 were significant predictors for disease progression. Multivariate Cox analysis showed KL-6 and MMP-7 were significantly associated with survival along with other variables.
The serum levels of KL-6 and MMP-7 were elevated in the individuals with interstitial lung disease compared with healthy controls. The rate of poor prognosis and mortality more associated with the variability increased biomarker concentrations，rather than the baseline concentration.Therefore，Serial measurements of biomarkers contribute to the disease monitoring in clinical management.
- Conditions
- Interstitial Lung Disease, Desquamative
- Keywords
- KL-6, disease progression, predict, biomarkers, MMP-7
- Medical subject headings
- Interstitial Pneumonitis, Desquamative, Familial, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease
Serum samples were prospectively collected from 70 patients including baseline, 1 month, 2 months, 6 months and 12 months, which were tested for a panel of Krebs van den Lungen-6 antigen (KL-6), by latex agglutination test.We have demonstrated that an increase in serum KL-6 levels, but not the level at any one point in time, predicts poor prognosis.
Measured: 3 years
Secondary outcomes (1)
Sequential Changes of Serum MMP-7 Predict Progression in Interstitial Lung Disease
Serum samples were prospectively collected from 70 patients including baseline, 1 month, 2 months, 6 months and 12 months, which were tested for a panel of matrix metalloproteinase-7 (MMP-7), by ELISA-based.We have demonstrated that an increase in serum MMP-7 levels, but not the level at any one point in time, predicts poor prognosis.
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 posted10 Nov 2016 (estimated)
- Study startMar 2013
- Primary completionOct 2016
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease, DesquamativeStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jiang, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960672
- Sponsor's protocol ID
- gyfyy
- Status last verified
- Nov 2016
- First submitted
- 27 Oct 2016
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02960672
- Acronym / sponsor ID
- gyfyy
- Conditions
- Interstitial Lung Disease, Desquamative
- Keywords
- KL-6, disease progression, predict, biomarkers, MMP-7
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Nov 2016 (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.
Interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly variable clinical process.thence it is significant for the patient to search a convenient and accurate prediction method. The objective of this study was to determine whether peripheral blood biomarkers can predict disease .
Detailed description
The median follow-up period was 12 months, each patient received 4 or 5 follow-ups in our center, 336 person-times in study enrollment totally. The patients with interstitial lung disease had significantly higher serum baseline KL-6 and MMP-7 levels compared with healthy control.They divided into progressive group and non-progressive group according to disease change. Serum KL-6 and MMP-7 levels were elevated in patients if disease progression, but baseline level of biomarkers in progressive group were not significant higher compare with non-progressive group .Binary logistic regression showed △KL-6 and △MMP-7 were significant predictors for disease progression. Multivariate Cox analysis showed KL-6 and MMP-7 were significantly associated with survival along with other variables.
The serum levels of KL-6 and MMP-7 were elevated in the individuals with interstitial lung disease compared with healthy controls. The rate of poor prognosis and mortality more associated with the variability increased biomarker concentrations，rather than the baseline concentration.Therefore，Serial measurements of biomarkers contribute to the disease monitoring in clinical management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects with a diagnosis of idiopathic interstitial pneumonias made in accordance with the American Thoracic Society (ATS)/European Respiratory Society (ERS) consensus classification
Key inclusion criteria (1 listed)
- Clinical diagnosis of interstitial lung disease
Key exclusion criteria (2 listed)
- Diagnosise of interstitial lung disease acute excerbation
- Combined pulmonary embolism, pulmonary edema, pulmonary tuberculosis, and peumonias
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
Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease
Time frame: 3 years
Serum samples were prospectively collected from 70 patients including baseline, 1 month, 2 months, 6 months and 12 months, which were tested for a panel of Krebs van den Lungen-6 antigen (KL-6), by latex agglutination test.We have demonstrated that an increase in serum KL-6 levels, but not the level at any one point in time, predicts poor prognosis.
1 secondary outcome
Sequential Changes of Serum MMP-7 Predict Progression in Interstitial Lung Disease
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Individual participant dataSharing planned: No
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?
An observational study of Interstitial Lung Disease, Desquamative, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in 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 1 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 10 Nov 2016. 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 China. 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?
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?
Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease (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 10 Nov 2016.