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Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease

Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02960672
Enrollment
70
Registered
2016-11-10
Start date
2013-03-31
Completion date
2018-12-31
Last updated
2016-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease, Desquamative

Keywords

KL-6, disease progression, predict, biomarkers, MMP-7

Brief 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 .

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.

Interventions

None listed

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 68 Years
Healthy volunteers
Yes

Inclusion criteria

r: * Clinical diagnosis of interstitial lung disease

Exclusion criteria

* Diagnosise of interstitial lung disease acute excerbation * Combined pulmonary embolism, pulmonary edema, pulmonary tuberculosis, and peumonias

Design outcomes

Primary

MeasureTime frameDescription
Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease3 yearsSerum 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.

Secondary

MeasureTime frameDescription
Sequential Changes of Serum MMP-7 Predict Progression in Interstitial Lung Disease3 yearsSerum 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026