ClinicalTrials.gg
Not yet recruitingNCT07869329Updated Oct 9, 2026

Biomarker Testing to Predict Radiation-Related Heart Disease in Lung Cancer Patients

An interventional study of Serum Pro-N-Cadherin Biomarker Assessment and Echocardiogram in Non-Small Cell Lung Cancer and Radiation-Induced Cardiac Disease, sponsored by Duke University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Duke University · Not applicable, Interventional, and Diagnostic

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. Participants will undergo blood collection and echocardiography over a two-year follow-up period.

02

Conditions studied

  • Non-Small Cell Lung Cancer
  • Radiation-Induced Cardiac Disease

Keywords

  • Biomarkers
  • Radiation-Induced Heart Disease
  • Non-Small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 50 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥ 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

Exclusion criteria

Exclusion Criteria:

  • 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).
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Adults with non-small cell lung cancer

    Adults with non-small cell lung cancer receiving hypofractionated radiation therapy will undergo biomarker testing and echocardiographic assessments.

    Diagnostic Test: Serum Pro-N-Cadherin Biomarker Assessment · Diagnostic Test: Echocardiogram

Interventions

  • Diagnostic testSerum Pro-N-Cadherin Biomarker Assessment

    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.

  • Diagnostic testEchocardiogram

    Participants will undergo two echocardiograms to measure heart function.

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What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Number of participants with cardiac events

    Time frame: 6, 12, 18, and 24 months post completion of radiation therapy

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2030, 48 months later.

Of 305 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 123. This study's planned 48 months is below that.

Counting every sponsor, half of 320 studies reached it within 52 months; a quarter within 28 and three quarters within 123.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 9, 2026
StartEst.
Nov 2026
Primary completionEst.
Nov 2030
CompletionEst.
Nov 2030
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869329
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2030 (estimated)
Completion
Nov 2030 (estimated)
Last update
Oct 9, 2026

Study contacts

Clinical Trials Office
Contact
RadOnc-Clinical_Trials@dm.duke.edu
(919) 668-3726
Christopher Kelsey, MD
principal investigator · Duke Health
Chang-Lung Lee, PhD
principal investigator · Duke Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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