Blood biomarkers to help tell if a lung nodule is cancer or not

Is this trial a fit for you?

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 tests multiple blood biomarkers, including protein markers, AHRR methylation, and fragmentome/methylome analyses of cell-free DNA, to predict lung cancer risk in patients with an incident lung nodule. Researchers will collect baseline blood samples from about 1,200 patients and use machine learning to combine biomarker results with clinical and radiologic features to improve risk estimates. The study follows REMARK guidelines to assess predictive performance and practicality for routine clinical use in a pulmonology/biochemistry setting. It is an observational study focusing on risk stratification to potentially reduce unnecessary invasive procedures. All participants are patients referred for work-up of a new solitary pulmonary nodule who sign informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with a newly detected IPN suspected of lung cancer referred to the infiltrate unit
* Having signed informed consent

Exclusion Criteria:

* Active cancer, excluding non-melanoma skin cancer
* Comorbidities that exclude the patient from clinical follow-up and final diagnosis

Where it's running

• Gentofte Hospital
  Gentofte Municipality, Denmark Recruiting

Study contacts

• Study coordinator: Søren Egstrand, MD, PhD
• Email: soeren.egstrand@regionh.dk
• Phone: 0045 21682147

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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.