Non-Invasive Malignancy Classifiers Using Blood-Biomarkers for Lung Nodule Evaluation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHerlev and Gentofte Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with a newly detected IPN suspected of lung cancer referred to the infiltrate unit
Having signed informed consent
Disqualifiers
Active cancer, excluding non-melanoma skin cancer
Comorbidities that exclude the patient from clinical follow-up and final diagnosis
Trial population
Patients referred to the infiltrate unit at the Dept. of Pulmonology, Gentofte Hospital, Denmark
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Blood tests
Diagnostic testStandard 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
Treatment groups
1,800 Participants
are divided into 1 treatment groupGroup A: Patients referred for work-up suspected of lung cancer1 intervention
Trial outcomes
Primary outcomes
1
Lung cancer diagnosis during work-up
Time frame
At least two years of followupSponsors and contacts
Click on the lead sponsor to view all of their trials.
Herlev and Gentofte Hospital
Lead sponsor
NEYE Foundation
Collaborator
Direktør Michael Hermann Nielsens mindelegat, afd B
Collaborator
Toyota Foundation Denmark
Collaborator
Grosserer L. F. Foghts Fond Denmark
Collaborator
Beckett Foundation
Collaborator
P. A. Messerschmidt & hustrus Fond
Collaborator
Source ClinicalTrials.gov