Lung Cancer (Diagnosis)NIMBLENCT07623473
Non-Invasive Malignancy Classifiers Using Blood-Biomarkers for Lung Nodule Evaluation
An observational study of Lung Cancer (Diagnosis) and Nodule, Solitary Pulmonary, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer (Diagnosis), Nodule, Solitary Pulmonary
- What is being tested?
- Blood tests
- How many people
- 1,800 participants
- Where
- 1 siteDenmark
- Study dates
- 22 May 2024to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients referred to the infiltrate unit at the Dept. of Pulmonology, Gentofte Hospital, Denmark
Who may be able to join
- Patients with a newly detected IPN suspected of lung cancer referred to the infiltrate unit
- Having signed informed consent
Who cannot join
- Active cancer, excluding non-melanoma skin cancer
- Comorbidities that exclude the patient from clinical follow-up and final diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Gentofte Hospital
Gentofte Municipality
Søren Egstrand, MD, PhD, 0045 21682147, soeren.egstrand@regionh.dk
About this study
Official title: 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.
Read the 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.
- Being tested
- Blood tests
- Keywords
- Biomarkers, Lung nodule, Fragmentomics, Methylome, Cell-free DNA
- Medical subject headings
- Lung Neoplasms, Disease, Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for work-up suspected of lung cancer | Patients are enrolled when these are referred to the Pulmonology Department suspected of lung cancer. Receives: Diagnostic Test: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer diagnosis during work-up
Measured: At least two years of followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start22 May 2024
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NEYE Foundation, Direktør Michael Hermann Nielsens mindelegat, afd B, Toyota Foundation Denmark, Grosserer L. F. Foghts Fond Denmark, Beckett Foundation, P. A. Messerschmidt & hustrus Fond
- Responsible party
- Principal investigator, Søren Egstrand, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623473
- Sponsor's protocol ID
- p-2024-15901
- Other IDs
- H-23045674
- Acronym
- NIMBLE
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIMBLE | Non-Invasive Malignancy Classifiers Using Blood-Biomarkers for Lung Nodule Evaluation
- ClinicalTrials.gov ID
- NCT07623473
- Acronym / sponsor ID
- NIMBLE / p-2024-15901
- Keywords
- Biomarkers, Lung nodule, Fragmentomics, Methylome, Cell-free DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- NEYE Foundation, Direktør Michael Hermann Nielsens mindelegat, afd B, Toyota Foundation Denmark, Grosserer L. F. Foghts Fond Denmark, Beckett Foundation, P. A. Messerschmidt & hustrus Fond
- Study start
- 22 May 2024 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for work-up suspected of lung cancer | – | Diagnostic Test: Blood testsPatients are enrolled when these are referred to the Pulmonology Department suspected of lung cancer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to the infiltrate unit at the Dept. of Pulmonology, Gentofte Hospital, Denmark
Key inclusion criteria (2 listed)
- Patients with a newly detected IPN suspected of lung cancer referred to the infiltrate unit
- Having signed informed consent
Key exclusion criteria (2 listed)
- Active cancer, excluding non-melanoma skin cancer
- Comorbidities that exclude the patient from clinical follow-up and final diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testsStandard 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 | Diagnostic test | Patients referred for work-up suspected of lung cancer |
Primary outcome
Lung cancer diagnosis during work-up
Time frame: At least two years of followup
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Cancer (Diagnosis)
RecruitingObservational study
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Brain Metastases, Bone Metastases
Active, not recruitingPhase 3
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Carcinoma, Non-Small-Cell Lung
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
RecruitingPhase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
Recurrent Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
Enrolling by invitationObservational study
Patient Reported Outcomes Following Percutaneous Lung Ablation
Lung Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Diagnosis) and Nodule, Solitary Pulmonary, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Søren Egstrand, MD, PhD (0045 21682147, soeren.egstrand@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer diagnosis during work-up (time frame: At least two years of followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.