Health TrialsbyHealthPanel

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

ConditionsNon-Small Cell Lung CancerRadiation-Induced Cardiac Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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)

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Serum Pro-N-Cadherin Biomarker Assessment

    Diagnostic 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.

  • Echocardiogram

    Diagnostic test

    Participants will undergo two echocardiograms to measure heart function.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Adults with non-small cell lung cancerExperimental treatment 2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: