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

NCT07669493 | Recruiting

• 1 other identifier: 2026KY184-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MACE, Arrhythmia, Pericardial Effusion and Survival

Outcome Measures

Primary Outcomes (1)

• cardiac safety

  From enrollment to the end of thoracic radiotherapy at 3 months

Study Arms (1)

Patients with thoracic tumors receiving thoracic radiotherapy

Identify early clinical or subclinical cardiac changes after thoracic radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Pericardial Effusion

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wu

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yajing Wu, MD

CONTACT

+8618531118178; wjzs19881212@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: January 17, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)