NCT07869329

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable nonsmall-cell-lung-cancer

Timeline
49mo left

Started Nov 2026

Typical duration for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

4 years

First QC Date

October 6, 2026

Last Update Submit

October 6, 2026

Conditions

Non-Small Cell Lung CancerRadiation-Induced Cardiac Disease

Keywords

BiomarkersRadiation-Induced Heart DiseaseNon-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • Pro-N-Cadherin biomarker level measured in ng/ml

    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

    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

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

Study Arms (1)

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.

Diagnostic Test: Serum Pro-N-Cadherin Biomarker AssessmentDiagnostic Test: Echocardiogram

Interventions

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.

Adults with non-small cell lung cancer
EchocardiogramDIAGNOSTIC_TEST

Participants will undergo two echocardiograms to measure heart function.

Adults with non-small cell lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 42492123BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Christopher Kelsey, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

  • Chang-Lung Lee, PhD

    Duke Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Office

CONTACT

(919) 668-3726RadOnc-Clinical_Trials@dm.duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 9, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)