Clinical trial Recruiting at 9 sites Observational Ages 18 and up

Blood biomarker study for early lung cancer diagnosis

Official title: Nodule IMmunophenotyping Biomarker for Lung Cancer Early Diagnosis Study

Run by Royal Marsden NHS Foundation Trust · NCT05432739 · Data updated 2026-11-12

This study is testing if certain blood markers can help tell if lung nodules are harmless or cancerous in patients who have had lung cancer before.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorRoyal Marsden NHS Foundation Trust
Academic / other
Locations9 sites (Goodmayes, Essex and 8 other locations)
StatusRecruiting
StartedApril 7, 2021
Main results expectedJanuary 1, 2026
Study endsJanuary 1, 2031
Registry record updatedJune 15, 2023
Trial IDNCT05432739 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 who are under active investigation or surveillance for incidental lung nodules.

Probably not a fit

Patients with active or recent malignancies, infections, or those unable to provide informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The NIMBLE study is a prospective observational study aimed at evaluating blood biomarkers in patients with lung nodules. It utilizes artificial intelligence and machine learning techniques to analyze data collected during routine patient care. The primary goal is to differentiate between benign and malignant lung nodules, particularly in patients with a history of lung cancer, and to determine whether a nodule represents a recurrence or a new primary cancer. This approach addresses the challenges of incidental lung nodules detected during CT scans, which often lead to unnecessary anxiety and additional testing.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of lung cancer, potentially improving patient outcomes.

How similar studies have gone: Other studies have shown promise in using AI and machine learning for cancer diagnosis, suggesting that this approach may be effective.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • Barking Havering and Redbridge University Hospitals NHS Trust
    Goodmayes, Essex, United Kingdom
    Recruiting
  • Calderdale and Huddersfield NHS Foundation Trust
    Huddersfield, United Kingdom
    Recruiting
  • Princess Alexandra Hospital
    London, United Kingdom
    Recruiting
  • Whittington Health NHS Trust
    London, United Kingdom
    Recruiting
  • University College London Hospitals NHS Foundation Trust
    London, United Kingdom
    Recruiting
  • Guy's and St Thomas' NHS Foundation Trust
    London, United Kingdom
    Recruiting
Show 3 more locations
  • Royal Marsden Hospital
    London, United Kingdom
    Recruiting
  • Northumbria NHS Foundation Trust
    Newcastle upon Tyne, United Kingdom
    Recruiting
  • Nottinghamshire Healthcare NHS Foundation Trust
    Nottingham, United Kingdom
    Recruiting

Study contacts

  • Principal investigator: Richard Lee, Dr — The Royal Marsden Hospitals NHS Trust
  • Study coordinator: Sejal Jain
  • Email: sejal.jain@rmh.nhs.uk
  • Phone: 02078082603

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.