Cardiac Safety Management and Immune Microenvironment Changes After Thoracic Radiotherapy: A Prospective Observational Study

Cardiac Safety Management and Immune Microenvironment Changes in Thoracic Cancer Patients Receiving Different Radiotherapy Modalities: A Prospective Observational Study

The goal of this observational study is to learn about cardiac safety monitoring after thoracic radiotherapy in adults with thoracic tumors.

The main question it aims to answer is:

Dose dynamic monitoring of cardiac biomarkers, electrocardiography, echocardiography, peripheral blood immune cell subsets, cytokines, chemokines, lipid profiles, and lipid metabolism markers help identify early clinical or subclinical cardiac changes after thoracic radiotherapy? Are cardiac substructure radiation dose parameters associated with early cardiac safety outcomes? Participants receiving thoracic radiotherapy as part of their regular medical care will complete cardiac safety assessments at the end of radiotherapy, 1 month after radiotherapy, and 3 months after radiotherapy.

Study Overview

• Status: Recruiting
• Conditions: MACE, Arrhythmia, Pericardial Effusion and Survival

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Yajing Wu, MD; Phone Number: +8618531118178; Email: wjzs19881212@163.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Fourth Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with lung cancer, metastatic lung cancer, esophageal cancer, breast cancer, or thymic tumors who received thoracic radiotherapy.

Description

Inclusion Criteria:

Patients willing to participate the research and sign the informed consent file; Patients aged ≥18 years; KPS≥70; Pathological diagnosis for lung cancer, metastatic lung cancer, esophageal cacner, breast cancer and thymus tumor; Patients received thoracic radiotherapy; No functional heart disease; LVEF≥50%

Exclusion Criteria:

Patients received thoracic radiotherapy previously; Patients with severe organic and functional disease; Unqualified patients with sufficient reasons; Cannot or no willing to sign the informed consent file

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with thoracic tumors receiving thoracic radiotherapy; Identify early clinical or subclinical cardiac changes after thoracic radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cardiac safety	From enrollment to the end of thoracic radiotherapy at 3 months

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: Wu, Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Pericardial Effusion
• Other Study ID Numbers: 2026KY184-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves clinical data, cardiac examination data, radiotherapy dose information, and blood biomarker data. These data may contain potentially identifiable or sensitive health information, and data sharing is not currently covered by the approved informed consent and institutional data-sharing policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No