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

NCT07623473 | Recruiting

• 2 other identifiers: p-2024-15901H-23045674
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer (Diagnosis); Nodule, Solitary Pulmonary

Keywords

Biomarkers; Lung nodule; Fragmentomics; Methylome; Cell-free DNA

Outcome Measures

Primary Outcomes (1)

• Lung cancer diagnosis during work-up

  At least two years of followup

Study Arms (1)

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

Interventions

Blood tests DIAGNOSTIC_TEST

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

Patients referred for work-up suspected of lung cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Gentofte Hospital

Gentofte Municipality, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (i.e. EDTA plasma, serum, buffy coat) are collected from all patients as soon as possible after referral for work-up. Tumor tissue (fresh) will be snap frozen in liquid nitrogen following resection for a subset of patients.

MeSH Terms

Conditions

Lung Neoplasms; Disease; Solitary Pulmonary Nodule

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Søren Egstrand, MD, PhD

CONTACT

0045 21682147; soeren.egstrand@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: May 22, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

DK (1)