Non-Small Cell Lung CancerNCT07869329
Biomarker Testing to Predict Radiation-Related Heart Disease in Lung Cancer Patients
A study testing Serum Pro-N-Cadherin Biomarker Assessment and Echocardiogram in people with Non-Small Cell Lung Cancer and Radiation-Induced Cardiac Disease, run by Duke University at 1 site in United States.
Trial summary
The study will measure serum Pro-N-Cadherin and NT-proBNP (pro B-type natriuretic peptide) levels in adults with non-small cell lung cancer receiving hypofractionated radiation therapy and evaluate whether these biomarkers correlate with radiation dose to the heart, cardiac dysfunction, and adverse cardiac events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Radiation-Induced Cardiac Disease
- What is being tested?
- Serum Pro-N-Cadherin Biomarker Assessment and Echocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2030
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Histologic documentation or clinical suspicion of non-small cell lung cancer based on pathology or imaging.
- Location of disease must be either a central right-sided tumor (defined as tumors with a planning target volume within 2 cm of the primary airways) arising below the level of the heart or any left-sided tumor arising below the level of the heart.
- Planned to receive hypofractionated radiation therapy (4-18 Gy fractions to a total dose of 45-70 Gy)
- Planning the target volume that is at or below the most superior aspect of the heart.
- Willing and able to provide written informed consent
Who cannot join
- Planning to receive concurrent or sequential chemotherapy or immunotherapy
- Prior radiation therapy to the chest that included more than a minimal dose to the heart (> 1 Gy mean dose).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Predicting Radiation-induced Cardiac Disease With the Biomarker Serum Pro-N-Cadherin
The study will measure serum Pro-N-Cadherin and NT-proBNP (pro B-type natriuretic peptide) levels in adults with non-small cell lung cancer receiving hypofractionated radiation therapy and evaluate whether these biomarkers correlate with radiation dose to the heart, cardiac dysfunction, and adverse cardiac events. Participants will undergo blood collection and echocardiography over a two-year follow-up period.
- Being tested
- Serum Pro-N-Cadherin Biomarker Assessment, Echocardiogram
- Keywords
- Biomarkers, Radiation-Induced Heart Disease, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Pro-N-Cadherin Biomarker AssessmentDiagnostic test
Serial blood collection for measurement of Pro-N-Cadherin and NT-proBNP (pro B-type natriuretic peptide) at baseline and follow-up timepoints, with correlation to cardiac radiation dose and outcomes.
EchocardiogramDiagnostic test
Participants will undergo two echocardiograms to measure heart function.
| Study group | Role | What they receive |
|---|---|---|
| Adults with non-small cell lung cancer | Experimental | Adults with non-small cell lung cancer receiving hypofractionated radiation therapy will undergo biomarker testing and echocardiographic assessments. Receives: Diagnostic Test: Serum Pro-N-Cadherin Biomarker Assessment; Diagnostic Test: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro-N-Cadherin biomarker level measured in ng/ml
Measured: Baseline, prior to starting radiation therapy (approximately 2 weeks); 6, 12, 18, and 24 months post completion of radiation therapy
Change in Pro-N-Cadherin biomarker level from baseline
Measured: Baseline, prior to starting radiation therapy (approximately 2 weeks); 6, 12, 18, and 24 months post completion of radiation therapy
Number of participants with cardiac events
Measured: 6, 12, 18, and 24 months post completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Kelsey, MD, Principal investigator, Duke HealthChang-Lung Lee, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869329
- Sponsor's protocol ID
- Pro00121209
- Other IDs
- U01AI189426
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrell PD, Neish D, Dugan GO, Schaaf GW, Olson JD, Oristian KM, Michalson KT, Niedzwiecki D, Kitzman D, Register TC, Cline JM, Pizzo SV, Lee CL. Serum Pro-N-Cadherin Correlates With Cardiac Injury in the Radiation Late Effects Cohort of Nonhuman Primates. JACC Adv. 2026 Aug;5(8):103050. doi: 10.1016/j.jacadv.2026.103050. Epub 2026 Jul 23.
PubMed 42492123
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Radiation-induced Cardiac Disease With the Biomarker Serum Pro-N-Cadherin
- ClinicalTrials.gov ID
- NCT07869329
- Acronym / sponsor ID
- Pro00121209
- Keywords
- Biomarkers, Radiation-Induced Heart Disease, Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 9 Oct 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 study will measure serum Pro-N-Cadherin and NT-proBNP (pro B-type natriuretic peptide) levels in adults with non-small cell lung cancer receiving hypofractionated radiation therapy and evaluate whether these biomarkers correlate with radiation dose to the heart, cardiac dysfunction, and adverse cardiac events. Participants will undergo blood collection and echocardiography over a two-year follow-up period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with non-small cell lung cancer | Experimental | Diagnostic Test: Serum Pro-N-Cadherin Biomarker Assessment, Diagnostic Test: EchocardiogramAdults with non-small cell lung cancer receiving hypofractionated radiation therapy will undergo biomarker testing and echocardiographic assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- Histologic documentation or clinical suspicion of non-small cell lung cancer based on pathology or imaging.
- Location of disease must be either a central right-sided tumor (defined as tumors with a planning target volume within 2 cm of the primary airways) arising below the level of the heart or any left-sided tumor arising below the level of the heart.
- Planned to receive hypofractionated radiation therapy (4-18 Gy fractions to a total dose of 45-70 Gy)
- Planning the target volume that is at or below the most superior aspect of the heart.
Key exclusion criteria (2 listed)
- Planning to receive concurrent or sequential chemotherapy or immunotherapy
- Prior radiation therapy to the chest that included more than a minimal dose to the heart (> 1 Gy mean dose).
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 |
|---|---|---|
| Serum Pro-N-Cadherin Biomarker AssessmentSerial blood collection for measurement of Pro-N-Cadherin and NT-proBNP (pro B-type natriuretic peptide) at baseline and follow-up timepoints, with correlation to cardiac radiation dose and outcomes. | Diagnostic test | Adults with non-small cell lung cancer |
| EchocardiogramParticipants will undergo two echocardiograms to measure heart function. | Diagnostic test | Adults with non-small cell lung cancer |
Primary outcome
Pro-N-Cadherin biomarker level measured in ng/ml
Time frame: Baseline, prior to starting radiation therapy (approximately 2 weeks); 6, 12, 18, and 24 months post completion of radiation therapy
Change in Pro-N-Cadherin biomarker level from baseline
Time frame: Baseline, prior to starting radiation therapy (approximately 2 weeks); 6, 12, 18, and 24 months post completion of radiation therapy
Number of participants with cardiac events
Time frame: 6, 12, 18, and 24 months post completion of radiation therapy
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 9 Oct 2026.
- Background: PubMed 42492123Ferrell PD, Neish D, Dugan GO, Schaaf GW, Olson JD, Oristian KM, Michalson KT, Niedzwiecki D, Kitzman D, Register TC, Cline JM, Pizzo SV, Lee CL. Serum Pro-N-Cadherin Correlates With Cardiac Injury in the Radiation Late Effects Cohort of Nonhuman Primates. JACC Adv. 2026 Aug;5(8):103050. doi: 10.1016/j.jacadv.2026.103050. Epub 2026 Jul 23.
- Individual participant dataSharing planned: No
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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.
Christopher Kelsey, MD principal investigator
Duke Health
Chang-Lung Lee, PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum Pro-N-Cadherin Biomarker Assessment and Echocardiogram in people with Non-Small Cell Lung Cancer and Radiation-Induced Cardiac Disease, run by Duke University at 1 site 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 6 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: opening soon, as of the sponsor's last update on 9 Oct 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 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?
Contact Clinical Trials Office ((919) 668-3726, RadOnc-Clinical_Trials@dm.duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pro-N-Cadherin biomarker level measured in ng/ml (time frame: Baseline, prior to starting radiation therapy (approximately 2 weeks); 6, 12, 18, and 24 months post completion of radiation therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07869329, which also lists 1 linked publication.
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 9 Oct 2026.