Blood biomarker study for early lung cancer diagnosis
Nodule IMmunophenotyping Biomarker for Lung Cancer Early Diagnosis Study
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 type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Locations | 9 sites (Goodmayes, Essex and 8 other locations) |
| Trial ID | NCT05432739 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are under active investigation or surveillance for incidental lung nodules.
Not a fit: Patients with active or recent malignancies, infections, or those unable to provide informed consent may not benefit from this study.
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 performed: Other studies have shown promise in using AI and machine learning for cancer diagnosis, suggesting that this approach may be effective.
Eligibility criteria
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 this trial is running
Goodmayes, Essex and 8 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.