Nodule IMmunophenotyping Biomarker for Lung Cancer Early Diagnosis Study

NCT05432739 | Recruiting

• 1 other identifier: NIMBLE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  To discover an immunophenotyping predictive classifier, to distinguish patients with benign versus malignant lung nodules.

  10 Years

Secondary Outcomes (1)

• Secondary Outcome

  10 Years

Other Outcomes (1)

• Exploratory Outcome

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have CT scans for lung changes (nodules) who meet the eligibility criteria.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Royal Marsden Partners West London Cancer Alliance: collaborator
• Imperial College London: collaborator
• University College London Hospitals: collaborator
• Lewisham and Greenwich NHS Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Epsom and St Helier University Hospitals NHS Trust: collaborator
• King's College Hospital NHS Trust: collaborator
• University College London (UCL) Cancer Institute: collaborator
• Institute of Cancer Research, United Kingdom: collaborator
• Francis Crick Institute: collaborator
• Royal Sussex County Hospital: collaborator

Study Sites (9)

Barking Havering and Redbridge University Hospitals NHS Trust

Goodmayes, Essex, IG3 8YB, United Kingdom

RECRUITING

Calderdale and Huddersfield NHS Foundation Trust

Huddersfield, HD3 3EA, United Kingdom

RECRUITING

Princess Alexandra Hospital

London, CM20 1QX, United Kingdom

RECRUITING

Whittington Health NHS Trust

London, N19 5NF, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

Northumbria NHS Foundation Trust

Newcastle upon Tyne, NE27 0QJ, United Kingdom

RECRUITING

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, NG3 6AA, United Kingdom

RECRUITING

Related Publications (22)

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• International Agency for Research on Cancer.

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  PMID: 31110349 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cell - 40ml at each sample collection point (4 x 10ml lithium heparin tubes) Formalin Fixed Paraffin Embedded Tumour Tissue - Archival only Fresh Tumour Tissue

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Richard Lee, Dr

  The Royal Marsden Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sejal Jain

CONTACT

02078082603; sejal.jain@rmh.nhs.uk

Laura Boddy

CONTACT

02078082603; laura.boddy@rmh.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 27, 2022
• Study Start: April 7, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: June 15, 2023

Record last verified: 2023-01

Locations

GB (9)