Longitudinal Changes in Serum KL-6 in IPF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2024-12-30

Brief Summary

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Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with a poor prognosis. More accurate tests to predict disease progression and response to treatment are required.

Krebs von den Lungen-6 (KL-6) is a blood marker associated with IPF. Results from previous studies have shown that levels of KL-6 are higher in patients with IPF compared to people without the disease. In addition, it is not clear what impact treatment has on KL-6 levels, and whether this could help us to monitor how effective treatment for IPF is.

The investigators plan to perform a study in which KL-6 levels in the blood of patients with a new diagnosis of IPF are measured at baseline, 3, 6 and 12 months to look for and changes in the levels of KL-6 in the blood.

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Detailed Description

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Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with a poor prognosis. Effective treatment which slows the progression of IPF has recently become available however, it is costly and at present is limited to patients who meet specific criteria based on their breathing tests. The breathing tests currently available to monitor progression of the disease are not always reliable and do not predict which patients will respond to treatment. More accurate tests to predict disease progression and response to treatment are required.

Krebs von den Lungen-6 (KL-6) is a blood marker associated with IPF. Results from previous studies have shown that levels of KL-6 are higher in patients with IPF compared to people without the disease. The majority of studies using KL-6 in IPF have taken place in Japan and there is limited evidence of how useful it is in a European population. In addition, it is not clear what impact treatment has on KL-6 levels, and whether this could help us to monitor how effective treatment for IPF is.

The investigators plan to perform a study in which KL-6 levels in the blood of patients with a new diagnosis of IPF are measured at baseline, 3, 6 and 12 months to look for and changes in the levels of KL-6 in the blood

The objective of this study is to assess changes in serum KL-6 levels in patients with IPF over a 12-month period and assess if this correlates with changes in lung function and if KL-6 levels change in response to treatment with antifibrotic therapy.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IPF patients

Patients with an MDT diagnosis of idiopathic pulmonary fibrosis. Patients will be observed over a 12 month period and have serial serum samples taken for KL-6 level.

Serum KL-6 level

Intervention Type DIAGNOSTIC_TEST

Serum blood biomarker which has been shown to be of interest in idiopathic pulmonary fibrosis

Interventions

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Serum KL-6 level

Serum blood biomarker which has been shown to be of interest in idiopathic pulmonary fibrosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Multi-disciplinary team (MDT) diagnosis of idiopathic pulmonary fibrosis as per international consensus guidelines

Exclusion Criteria

* Significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not IPF)
* FEV1/FVC ratio \< 70% on full lung function testing
* Current smoker (within 4 week of enrollment)
* Received treatment for acute lower respiratory tract infection with last 4 weeks
* Use of long-term (greater than 4 weeks) oral corticosteroids or immunosuppression within 4 weeks of enrolment
* Current participation in a double-blind placebo-controlled pharmaceutical trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No