ClinicalTrials.gg
RecruitingNCT07669493Updated Jun 25, 2026

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

An observational study in MACE, Arrhythmia, Pericardial Effusion and Survival, sponsored by Hebei Medical University Fourth Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Hebei Medical University Fourth Hospital · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • MACE, Arrhythmia, Pericardial Effusion and Survival
03

In context

Arrhythmias, Cardiac

1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Hebei Medical University Fourth Hospital is the lead sponsor of 81 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 file

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with thoracic tumors receiving thoracic radiotherapy

    Identify early clinical or subclinical cardiac changes after thoracic radiotherapy

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What researchers measure

Primary outcomes

  1. cardiac safety

    Time frame: From enrollment to the end of thoracic radiotherapy at 3 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 11 months after the start.

Of 189 non-industry observational studies under Arrhythmias, Cardiac, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 140. This study's planned 11 months is below that.

Counting every sponsor, half of 258 studies reached it within 38 months; a quarter within 16 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2026
First posted
Jun 25, 2026
StartActual
Jan 17, 2026
Primary completionEst.
Jan 1, 2027
CompletionEst.
Jan 1, 2027
Last update
Jun 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07669493
Lead sponsor
Hebei Medical University Fourth Hospital
Collaborators
National Natural Science Foundation of China
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
Jan 17, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Yajing Wu, MD
Contact
wjzs19881212@163.com
+8618531118178
Wu
principal investigator · Hebei Medical University Fourth Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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