iDx Lung
Research type
Research Study
Full title
Lung Health Checks in Wessex and Yorkshire: Integrated Biomarker Studies
IRAS ID
283721
Contact name
Peter Johnson
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
ISRCTN Number
ISRCTN39678730
Duration of Study in the UK
4 years, 6 months, 30 days
Research summary
Screening for lung cancer is being carried out in the NHS using low dose CT scans. This study will test whether adding blood or tissue biomarkers (tests that can detect molecules secreted by a tumour, or a specific response of the body to the presence of cancer) will help with screening for lung cancer in addition to a routine low-dose CT scan. This could help to improve the early diagnosis of lung cancer, and thereby survival, in the future.
People undergoing a routine NHS Targeted Lung Health Check (TLHC) in Wessex or Yorkshire will be approached by a member of the clinical team, or an appropriately trained member of the research team, and asked if they are willing to participate in this study. If participants consent to the study, they will have a single blood sample taken, and a tissue sample taken from inside the nose with a swab. The blood taken will be analysed to detect biomarkers (antibodies, circulating tumour DNA, or abnormal protein markers in the blood) and the sample from the nose will be analysed to measure the patterns of gene expression in the lining of the air passages.
No additional visits for the study will be required. No additional clinical data will be collected for the study beyond the information routinely collected by the NHS. Permission will be sought to enable surplus samples to be stored for future ethically-approved research.
One of the blood tests, called EarlyCDT Lung, has a a CE mark for use as an in vitro diagnostic. The results of this test will be fed back to the TLHC clinical team in case it is helpful in deciding whether a person would benefit from further investigation.
REC name
London - Surrey Research Ethics Committee
REC reference
21/PR/0211
Date of REC Opinion
12 Mar 2021
REC opinion
Favourable Opinion