Longitudinal Changes in Serum KL-6 in IPF

NCT04268485 | Unknown

• 1 other identifier: ManchesterUNHS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

KL-6; Krebs von den Lungen-6; Biomarker

Outcome Measures

Primary Outcomes (1)

• Serum KL-6 level

  Change in serum KL-6 level between baseline and 12 months

  12 months

Secondary Outcomes (8)

• Serum KL-6 level at 3, 6 months

  3 and 6 months

• KL-6 forced vital capacity (FVC) correlation

  3, 6 and12 months

• KL-6 diffusion capacity (DLCO)

  3, 6 and12 months

• KL-6 symptoms

  3, 6 and12 months

• KL-6 antifibrotics

  12 months

Study Arms (1)

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.

Diagnostic Test: Serum KL-6 level

Interventions

Serum KL-6 level DIAGNOSTIC_TEST

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

IPF patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an MDT diagnosis of idiopathic pulmonary fibrosis attending routine follow-up care

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University hospitals NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples taken on four separate visits over 12 months. Samples tested for KL-6 level onyl

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Medullary cystic kidney disease 1

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Conal Hayton

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Conal Hayton, MBChB

CONTACT

+441612915388; conalhayton@doctors.org.uk

Nazia Chaudhuri

CONTACT

+441612915054; nazia.chaudhuri@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)