Non-Invasive Malignancy Classifiers Using Blood-Biomarkers for Lung Nodule Evaluation (NIMBLE)

NIMBLE | Non-Invasive Malignancy Classifiers Using Blood-Biomarkers for Lung Nodule Evaluation

The goal of the NIMBLE study is to evaluate blood-based biomarkers for lung cancer risk prediction in patients referred with a lung nodule.

Each blood biomarker will be evaluated for descriminating malignant from benign lung nodules alone and in combination with other blood biomarkers, patient characteristics and radiological features.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer (Diagnosis); Nodule, Solitary Pulmonary
• Intervention / Treatment: Diagnostic test: Blood tests

Detailed Description

Lung nodules are frequent findings on chest CT scans. The majority of nodules are benign, but a substantial fraction will be malignant. The decision to pursue invasive diagnostics currently rely on a risk estimate based on patient characteristics and radiological features of the nodule.

Accurate risk estimation is crucial as invasive diagnostics comes with a significant risk of severe complications such as collapsed lung, bleeding, infections and in rare cases death. The NIMBLE project seeks to improve the early risk assessment by incorporation of blood biomarkers in the risk algorithm. The study will include 1,200 patients with a nodule when patients are referred to the dept. of pulmonology and perform an addition blood draw. The blood will be analyzed using a wide range of blood tests. These will include standard blood tests, novel protein tumor markers specifically targeting lung cancer, an epigenetic smoking marker (AHRR methylation), and combined fragmentome, mutational and methylome analysis of cell-free tumor DNA.

Blood tests will be evaluated following REMARK guidelines in terms of lung cancer predictive performance but also in terms of feasibility in implementation in daily routine testing at a Dept. of Clinical Biochemistry.

The study will perform all tests on patient material collected at baseline when patients are referred to work-up and use machine learning to optimally combine blood tests with patient characteristics and radiological features.

• Study Type: Observational
• Enrollment (Estimated): 1800

Contacts and Locations

• Study Contact: Name: Søren Egstrand, MD, PhD; Phone Number: 0045 21682147; Email: soeren.egstrand@regionh.dk

Study Locations

• Denmark
  • Gentofte Municipality, Denmark
    • Recruiting
    • Gentofte Hospital
    • Contact: Søren Egstrand, MD, PhD; Phone Number: 0045 21682147; Email: soeren.egstrand@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the infiltrate unit at the Dept. of Pulmonology, Gentofte Hospital, Denmark

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients referred for work-up suspected of lung cancer; Patients are enrolled when these are referred to the Pulmonology Department suspected of lung cancer.	Diagnostic test: Blood tests; Standard blood tests, Novel protein tumor markers specifically targeting lung cancer, Epigenetic smoking marker (AHRR methylation), Combined fragmentome, mutational and methylome analysis of cell-free tumor DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lung cancer diagnosis during work-up	At least two years of followup

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: Grosserer L. F. Foghts Fond Denmark; Beckett Foundation; Toyota Foundation Denmark; NEYE Foundation; Direktør Michael Hermann Nielsens mindelegat, afd B; P. A. Messerschmidt & hustrus Fond

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; Cell-free DNA; Lung nodule; Methylome; Fragmentomics
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease; Solitary Pulmonary Nodule; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: p-2024-15901; H-23045674 (Other Identifier: Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No