Monitoring KL-6 levels in patients with idiopathic pulmonary fibrosis
Longitudinal Changes in Serum KL-6 Levels in Idiopathic Pulmonary Fibrosis (LOCK-IPF)
This study is testing if measuring a specific protein in the blood can help doctors understand how well treatments are working for people newly diagnosed with idiopathic pulmonary fibrosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust Government |
| Locations | 1 site (Manchester) |
| Trial ID | NCT04268485 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure serum levels of KL-6, a biomarker associated with idiopathic pulmonary fibrosis (IPF), in patients newly diagnosed with the condition. Blood samples will be collected at baseline and then at 3, 6, and 12 months to assess changes in KL-6 levels over time. The study seeks to determine if these changes correlate with lung function and treatment response, providing insights into the effectiveness of current therapies for IPF. The research is particularly focused on understanding KL-6's utility in a European population, as most prior studies have been conducted in Japan.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a multidisciplinary team diagnosis of idiopathic pulmonary fibrosis.
Not a fit: Patients with significant respiratory co-morbidities or those currently participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate monitoring of disease progression and treatment response in patients with IPF.
How similar studies have performed: While KL-6 has been studied primarily in Japan, this study represents a novel approach to assessing its utility in a European context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Manchester
- Manchester University hospitals NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Conal Hayton — Manchester University NHS Foundation Trust
- Study coordinator: Conal Hayton, MBChB
- Email: conalhayton@doctors.org.uk
- Phone: +441612915388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.