RecruitingNCT07623473

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

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


Sponsor

Herlev and Gentofte Hospital

Enrollment

1,800 participants

Start Date

May 22, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria2

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

Exclusion Criteria2

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

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Interventions

DIAGNOSTIC_TESTBlood 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


Locations(1)

Gentofte Hospital

Gentofte Municipality, Denmark

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NCT07623473


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