Nodule IMmunophenotyping Biomarker for Lung Cancer Early Diagnosis Study

NIMBLE is a prospective study for blood biomarker study of lung nodules alongside analysing data which has been collected routinely as part of patient care. The primary aim of NIMBLE is to assess whether artificial intelligence and machine learning based radiomics approaches can be used to distinguish between benign disease and malignancy in a new lung nodule after a previously treated cancer, and where malignant to differentiate between metastatic recurrence or a new primary lung cancer.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Patients under active investigation or surveillance for incidental lung nodules
* Age \> 18.

Exclusion Criteria:

* Active or previous diagnosis of malignancy (within 5 years preceding baseline scan).
* Inability to give informed consent.
* Active infection (including tuberculosis or fungal infection).
* Clinician-suspected or confirmed active or recent COVID-19 infection (less than 4 weeks before CT scan or required blood sampling date).

• BACKGROUNDNational Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641
• BACKGROUNDvan Klaveren RJ, Oudkerk M, Prokop M, Scholten ET, Nackaerts K, Vernhout R, van Iersel CA, van den Bergh KA, van 't Westeinde S, van der Aalst C, Thunnissen E, Xu DM, Wang Y, Zhao Y, Gietema HA, de Hoop BJ, Groen HJ, de Bock GH, van Ooijen P, Weenink C, Verschakelen J, Lammers JW, Timens W, Willebrand D, Vink A, Mali W, de Koning HJ. Management of lung nodules detected by volume CT scanning. N Engl J Med. 2009 Dec 3;361(23):2221-9. doi: 10.1056/NEJMoa0906085. PMID 19955524
• BACKGROUNDSverzellati N, Silva M, Calareso G, Galeone C, Marchiano A, Sestini S, Sozzi G, Pastorino U. Low-dose computed tomography for lung cancer screening: comparison of performance between annual and biennial screen. Eur Radiol. 2016 Nov;26(11):3821-3829. doi: 10.1007/s00330-016-4228-3. Epub 2016 Feb 11. PMID 26868497
• BACKGROUNDPaci E, Puliti D, Lopes Pegna A, Carrozzi L, Picozzi G, Falaschi F, Pistelli F, Aquilini F, Ocello C, Zappa M, Carozzi FM, Mascalchi M; the ITALUNG Working Group. Mortality, survival and incidence rates in the ITALUNG randomised lung cancer screening trial. Thorax. 2017 Sep;72(9):825-831. doi: 10.1136/thoraxjnl-2016-209825. Epub 2017 Apr 4. PMID 28377492
• BACKGROUNDInfante M, Cavuto S, Lutman FR, Brambilla G, Chiesa G, Ceresoli G, Passera E, Angeli E, Chiarenza M, Aranzulla G, Cariboni U, Errico V, Inzirillo F, Bottoni E, Voulaz E, Alloisio M, Destro A, Roncalli M, Santoro A, Ravasi G; DANTE Study Group. A randomized study of lung cancer screening with spiral computed tomography: three-year results from the DANTE trial. Am J Respir Crit Care Med. 2009 Sep 1;180(5):445-53. doi: 10.1164/rccm.200901-0076OC. Epub 2009 Jun 11. PMID 19520905