Radiation TherapyNCT04443400
Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy
An observational study of Radiation Therapy, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to detecte and predict early subclinical cardiac damage induced by thoracic radiation therapy based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiation Therapy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with thoracic radiotherapy
Who may be able to join
- with malignant tumors
- will receive radiotherapy
- with cardiac exposure during the radiotherapy process
- could receive regular follow-up for 12 months
- written informed consent
Who cannot join
- satisfactory echocardiographic images could not be obtained
- moderate or severe valvular disease
- cardiomyopathy
- congenital heart disease
- refractory hypertension
- coronary artery disease*
Show all 16Show fewer
- heart failure
- arrhythmia requiring intervention
- pericarditis
- acute myocarditis
- participating in other clinical studies of drug intervention
- severe liver and kidney dysfunction
- autoimmune disease
- pulmonary hypertension
- coronary artery disease: at least 50% stenosis besed on previous coronary angiography or CTA, or with a history of percutaneous coronary stent implantation.
- : with LVEF<50%, unstable angina，or acute myocardial infarction within 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Dan Zhu, +8613810103532 ext. +8613810103532, andrea_zhu@163.com
Tingcui Li, +8618801236290 ext. +8618801236290, tingcui2019@163.com
About this study
The purpose of this study is to detecte and predict early subclinical cardiac damage induced by thoracic radiation therapy based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers.
Read the detailed description
This is a monocentric prospective cohort study in which 100 patients treated for malignant tumors and with cardiac radiation exposure will be included.All patient will be followed for 12 months after radiotherapy. Echocardiography, 2D STE parameters and circulating biomarkers will be collected.
- Conditions
- Radiation Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy
To detecte early subclinical cardiac damage induced by thoracic radiation therapy, based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers
Measured: 2020-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Zhu, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443400
- Sponsor's protocol ID
- PekingUTN
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li T, Zhuang H, Wang Y, Li J, Zhu D, Cui M. Two-dimensional speckle tracking echocardiography in evaluating radiation-induced heart damage. Asia Pac J Oncol Nurs. 2021 Dec 25;9(2):119-124. doi: 10.1016/j.apjon.2021.12.008. eCollection 2022 Feb.
PubMed 35529415Zhu D, Li T, Zhuang H, Cui M. Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy: Study Protocol for a Prospective Cohort Study. Front Cardiovasc Med. 2022 Jan 26;8:735265. doi: 10.3389/fcvm.2021.735265. eCollection 2021.
PubMed 35155592
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy
- ClinicalTrials.gov ID
- NCT04443400
- Acronym / sponsor ID
- PekingUTN
- Conditions
- Radiation Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Jun 2020 (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 purpose of this study is to detecte and predict early subclinical cardiac damage induced by thoracic radiation therapy based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers.
Detailed description
This is a monocentric prospective cohort study in which 100 patients treated for malignant tumors and with cardiac radiation exposure will be included.All patient will be followed for 12 months after radiotherapy. Echocardiography, 2D STE parameters and circulating biomarkers will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with thoracic radiotherapy
Key inclusion criteria (5 listed)
- with malignant tumors
- will receive radiotherapy
- with cardiac exposure during the radiotherapy process
- could receive regular follow-up for 12 months
- written informed consent
Key exclusion criteria (16 listed)
- satisfactory echocardiographic images could not be obtained
- moderate or severe valvular disease
- cardiomyopathy
- congenital heart disease
- refractory hypertension
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
Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy
Time frame: 2020-2021
To detecte early subclinical cardiac damage induced by thoracic radiation therapy, based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 35529415Li T, Zhuang H, Wang Y, Li J, Zhu D, Cui M. Two-dimensional speckle tracking echocardiography in evaluating radiation-induced heart damage. Asia Pac J Oncol Nurs. 2021 Dec 25;9(2):119-124. doi: 10.1016/j.apjon.2021.12.008. eCollection 2022 Feb.
- Derived from this study: PubMed 35155592Zhu D, Li T, Zhuang H, Cui M. Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy: Study Protocol for a Prospective Cohort Study. Front Cardiovasc Med. 2022 Jan 26;8:735265. doi: 10.3389/fcvm.2021.735265. eCollection 2021.
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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. This study is not recruiting at the moment.
Dan Zhu study director
Peking University Third 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 Radiation Therapy, run by Peking University Third 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Zhu, M.D. (+8613810103532 ext. +8613810103532, andrea_zhu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy (time frame: 2020-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443400, which also lists 2 linked publications.
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 23 Jun 2020.