MACE, Arrhythmia, Pericardial Effusion and SurvivalNCT07669493
Cardiac Safety Management and Immune Microenvironment Changes After Thoracic Radiotherapy: A Prospective Observational Study
An observational study of MACE, Arrhythmia, Pericardial Effusion and Survival, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MACE, Arrhythmia, Pericardial Effusion and Survival
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with lung cancer, metastatic lung cancer, esophageal cancer, breast cancer, or thymic tumors who received thoracic radiotherapy.
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: 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.
- Medical subject headings
- Arrhythmias, Cardiac, Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with thoracic tumors receiving thoracic radiotherapy | Identify early clinical or subclinical cardiac changes after thoracic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac safety
Measured: From enrollment to the end of thoracic radiotherapy at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start17 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MACE, Arrhythmia, Pericardial Effusion and SurvivalStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor
- Investigators
- Wu, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669493
- Sponsor's protocol ID
- 2026KY184-01
- Status last verified
- Jan 2026
- First submitted
- 21 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Safety Management and Immune Microenvironment Changes in Thoracic Cancer Patients Receiving Different Radiotherapy Modalities: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07669493
- Acronym / sponsor ID
- 2026KY184-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with thoracic tumors receiving thoracic radiotherapy | – | –Identify early clinical or subclinical cardiac changes after thoracic radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with lung cancer, metastatic lung cancer, esophageal cancer, breast cancer, or thymic tumors who received thoracic radiotherapy.
Key inclusion criteria (1 listed)
- 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%
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiac safety
Time frame: From enrollment to the end of thoracic radiotherapy at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wu principal investigator
Hebei Medical University Fourth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MACE, Arrhythmia, Pericardial Effusion and Survival, run by Hebei Medical University Fourth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yajing Wu, MD (+8618531118178, wjzs19881212@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac safety (time frame: From enrollment to the end of thoracic radiotherapy at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.