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

Predicting Radiation-induced Cardiac Disease With the Biomarker Serum Pro-N-Cadherin

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether two blood markers, Pro-N-Cadherin and NT-proBNP, can help predict heart problems linked to radiation. It is for adults with non-small cell lung cancer who will get larger doses of radiation in fewer treatments. Participants will have blood tests and heart ultrasounds over two years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have non-small cell lung cancer confirmed by tissue tests, or suspected based on tissue tests or scans.
  • Have a tumor below the level of the heart: either on the left side, or on the right side with the planned treatment area within 2 cm of the main airways.
  • Plan to get radiation in larger doses per treatment: 4–18 Gy each, for a total of 45–70 Gy. Gy is a unit of radiation dose.
  • The planned treatment area must be at or below the top of the heart.
  • Be willing and able to sign a form agreeing to join the study.

Who can't join

  • Plan to get chemotherapy or immunotherapy, either along with radiation or before or after it. These are medicines used to treat cancer.
  • Have had chest radiation that gave the heart an average dose of more than 1 Gy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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: * 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).

Study sites (1)

NC