Clinical trial · Observational
'Lung Health Check' Biomarker Study
Lung Health Check Biomarker Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
CT screening of lung cancer offers an opportunity to diagnose early stage lung cancers which is associated with better prognosis - indeterminate results delay diagnosis whilst interval imaging is awaited to assess risk of cancer. This study will allow us to examine the potential of blood-based biomarkers to augment CT screening for lung cancer. Hypotheses 1. Blood and sputum samples can be collected in patients attending lung health checks as part of the Lung Health Check pilot in West London at fixed and mobile scanners and safely transported for processing and storage in preparation for biomarker development. 2. The biomarkers will help to identify cohorts of 1. High-risk patients in whom CT surveillance should be conducted more readily/frequently and diagnostic procedures performed earlier. 2. Low-risk patients who might need reduced surveillance intensity. 3. Patients with interstitial lung abnormalities that share similar biomarker characteristics to patients with clinically significant interstitial lung disease
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Specimen | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Cohort A
- description
- Patients new to The Lung Health Check (TLHC) pilot who are attending their first lung health check
- interventionNames
- Diagnostic Test: Blood Specimen
- label
- Cohort B (Nodule Suveillance)
- description
- Patients who have already undergone one lung health check as part of the TLHC programme, and are now being followed up at 3 months (B1), 12 months (B2) or other (BX) due to an indeterminate finding (e.g. lung nodule)
- interventionNames
- Diagnostic Test: Blood Specimen
- label
- Cohort C (Incident Scan)
- description
- Patients who are already part of TLHC attending for routine 'incident' round follow-up scanning (usually at approximately 24 months)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients invited to participate in the Royal Marsden (RM) Partners Lung Health Check pilot study who undergo one or more CT scans: * Between the age of 55-75 years of age; and * Current smokers or ex-smokers who have quit after the age of 40. Exclusion Criteria: * Patients excluded from the Lung Health Check: * On the palliative care register; * Any active malignancy undergoing treatment * Daily activity levels equivalent to performance score 3 or 4; and * Unable to consent to Lung Health Check Biomarker Study
References
Publications (5)
- RESULTCohen JD, Li L, Wang Y, Thoburn C, Afsari B, Danilova L, Douville C, Javed AA, Wong F, Mattox A, Hruban RH, Wolfgang CL, Goggins MG, Dal Molin M, Wang TL, Roden R, Klein AP, Ptak J, Dobbyn L, Schaefer J, Silliman N, Popoli M, Vogelstein JT, Browne JD, Schoen RE, Brand RE, Tie J, Gibbs P, Wong HL, Mansfield AS, Jen J, Hanash SM, Falconi M, Allen PJ, Zhou S, Bettegowda C, Diaz LA Jr, Tomasetti C, Kinzler KW, Vogelstein B, Lennon AM, Papadopoulos N. Detection and localization of surgically resectable cancers with a multi-analyte blood test. Science. 2018 Feb 23;359(6378):926-930. doi: 10.1126/science.aar3247. Epub 2018 Jan 18. PMID 29348365
- RESULTWang BH, Li YY, Han JZ, Zhou LY, Lv YQ, Zhang HL, Zhao L. Gene methylation as a powerful biomarker for detection and screening of non-small cell lung cancer in blood. Oncotarget. 2017 May 9;8(19):31692-31704. doi: 10.18632/oncotarget.15919. PMID 28404957
- RESULTNewman AM, Bratman SV, To J, Wynne JF, Eclov NC, Modlin LA, Liu CL, Neal JW, Wakelee HA, Merritt RE, Shrager JB, Loo BW Jr, Alizadeh AA, Diehn M. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med. 2014 May;20(5):548-54. doi: 10.1038/nm.3519. Epub 2014 Apr 6. PMID 24705333
- RESULTYe M, Li S, Huang W, Wang C, Liu L, Liu J, Liu J, Pan H, Deng Q, Tang H, Jiang L, Huang W, Chen X, Shao D, Peng Z, Wu R, Zhong J, Wang Z, Zhang X, Kristiansen K, Wang J, Yin Y, Mao M, He J, Liang W. Comprehensive targeted super-deep next generation sequencing enhances differential diagnosis of solitary pulmonary nodules. J Thorac Dis. 2018 Apr;10(Suppl 7):S820-S829. doi: 10.21037/jtd.2018.04.09. PMID 29780628
- RESULTZhao H, Chen KZ, Hui BG, Zhang K, Yang F, Wang J. Role of circulating tumor DNA in the management of early-stage lung cancer. Thorac Cancer. 2018 May;9(5):509-515. doi: 10.1111/1759-7714.12622. Epub 2018 Mar 12. PMID 29528556