Pulmonary NoduleNCT06074133
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules
An observational study of Pulmonary Nodule, run by Vanderbilt-Ingram Cancer Center at 4 sites in United States.
Trial summary
This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pulmonary Nodule
- What is being tested?
- Blood collection and Chest Computed Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Mar 2024to 31 Mar 2029
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited from pulmonary or thoracic clinics that have indeterminate pulmonary nodules
Who may be able to join
- Adults > 21 y/o
- IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of Combined Biomarker Model
- Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model
- Solid nodules or part-solid nodules with solid component >=8mm
- CT scan with nodule of concern performed within 60 days of enrollment
Who cannot join
- Pure ground glass nodule or subsolid nodule with solid component <8mm
- Currently on therapy for any cancer
- History of primary lung cancer within the last 5 years
- Multiple nodules highly suspicious for metastatic disease
- Other malignancy within the last 2 year - Excluding skin cancer other than melanoma
- Pregnant women
Show all 9Show fewer
- Prisoners
- Inability to provide informed consent
- Serologic evidence of active fungal infection
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
University of Colorado
Aurora, Colorado, 80045
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37203
VA Tennessee Valley Healthcare Center
Nashville, Tennessee, 37212
About this study
Official title: A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study
This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial.
Read the detailed description
Objectives:
- To obtain the combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score in a prospective observational trial and estimate potential clinical utility compared to the Mayo Model.
- To establish standard operating procedures (SOPs) and protocols in a prospective observational trial in anticipation of a future randomized control trial. These include the REDCAP data input protocols, the radiomic protocols, blood draws in the CLIA environment, and estimating the CBM score in a time reasonable for clinical practice (< 2 weeks).
- Conditions
- Pulmonary Nodule
- Being tested
- Blood collection, Chest Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionProcedure or surgery
Undergo blood draw
Chest Computed TomographyProcedure or surgery
Undergo standard of care chest Computed Tomography
| Study group | Role | What they receive |
|---|---|---|
| Indeterminate Pulmonary Nodules | A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model. Receives: Procedure: Blood collection; Procedure: Chest Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with benign disease who underwent invasive diagnostic procedures.
Measured: Up to approximately 2 years
The time to diagnosis (in days) for patients with cancer.
Measured: Up to approximately 2 years
Measure time needed to provide the CBM Value to clinician
Number of days
Measured: Up to approximately 2 years
Measure time needed to obtain hs CYFRA 21-1 values
Number of hours (days)
Measured: Up to approximately 2 years
Measure time needed to perform radiomics
Number of hours (days)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start7 Mar 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NoduleStudies 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
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Eric Grogan, Vanderbilt-Ingram Cancer Center
- Investigators
- Eric Grogan, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074133
- Sponsor's protocol ID
- VICC-EDTHO23230
- Other IDs
- NCI-2023-05725, 5R01CA252964-02
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT06074133
- Acronym / sponsor ID
- VICC-EDTHO23230
- Conditions
- Pulmonary Nodule
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 10 Oct 2023 (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.
This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial.
Detailed description
Objectives:
- To obtain the combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score in a prospective observational trial and estimate potential clinical utility compared to the Mayo Model.
- To establish standard operating procedures (SOPs) and protocols in a prospective observational trial in anticipation of a future randomized control trial. These include the REDCAP data input protocols, the radiomic protocols, blood draws in the CLIA environment, and estimating the CBM score in a time reasonable for clinical practice (< 2 weeks).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indeterminate Pulmonary Nodules | – | Procedure: Blood collection, Procedure: Chest Computed TomographyA combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited from pulmonary or thoracic clinics that have indeterminate pulmonary nodules
Key inclusion criteria (5 listed)
- Adults > 21 y/o
- IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of Combined Biomarker Model
- Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model
- Solid nodules or part-solid nodules with solid component >=8mm
- CT scan with nodule of concern performed within 60 days of enrollment
Key exclusion criteria (9 listed)
- Pure ground glass nodule or subsolid nodule with solid component <8mm
- Currently on therapy for any cancer
- History of primary lung cancer within the last 5 years
- Multiple nodules highly suspicious for metastatic disease
- Other malignancy within the last 2 year - Excluding skin cancer other than melanoma
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 collectionUndergo blood draw | Procedure or surgery | Indeterminate Pulmonary Nodules |
| Chest Computed TomographyUndergo standard of care chest Computed Tomography | Procedure or surgery | Indeterminate Pulmonary Nodules |
Primary outcome
The proportion of patients with benign disease who underwent invasive diagnostic procedures.
Time frame: Up to approximately 2 years
The time to diagnosis (in days) for patients with cancer.
Time frame: Up to approximately 2 years
Measure time needed to provide the CBM Value to clinician
Time frame: Up to approximately 2 years
Number of days
Measure time needed to obtain hs CYFRA 21-1 values
Time frame: Up to approximately 2 years
Number of hours (days)
Measure time needed to perform radiomics
Time frame: Up to approximately 2 years
Number of hours (days)
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 4 May 2026.
- Individual participant dataSharing planned: No
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Study of Collection and Analysis of Clinical, Anamnestic, Functional, Biological Data Through the Support of Artificial Intelligence to Evaluate the Possibility of Defining a Digital Twin of the Lung (LUCE)
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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. This study is not recruiting at the moment.
Eric Grogan, MD principal investigator
Vanderbilt University/Ingram Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule, run by Vanderbilt-Ingram Cancer Center at 4 sites in United States.
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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with benign disease who underwent invasive diagnostic procedures. (time frame: Up to approximately 2 years). The study lists 5 primary outcomes in all. 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 4 May 2026.