Non-small Cell Lung CancerNCT05252065
Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Guizhou Medical University.
Trial summary
Calculating which cardiac substructure accepting with the highest radiation dose by conventional radiotherapy, then to investigate the relationship between the changes of global longitudinal strain or cardiac magnetic resonance imaging and cardiac biomarkers and the certain cardiac substructure for stage N2-3… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2022to 30 Dec 2022
- How long will I take part?
- 1 Month
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: patients with stage N2-3 non-small cell lung cancerreceive intensity-modulated radiotherapy (IMRT) from Guizhou medical university affiliated cancer hospital.
Who may be able to join
- Patients at TNM stage N2-N3 NSCLC confirmed by histopathology or cytology using IASLC International TNM staging standard (8th edition)
- KPS score >80; Aged 18 to 75 year-old
- No contraindications to radiotherapy
- No history of heart disease before treatment
- Patients receiving intensity modulated radiation therapy (IMRT)
- Patients receiving PTV at a prescription dose of 60-70Gy by IMRT
- Patients receiving radiotherapy alone and concurrent chemoradiotherapy
Who cannot join
- Patients with pleural effusion
- Patients with serious medical illness or infection
- Patients with acute myocardial infarction within 6 months
- In patients with NYHA grade 3-4, baseline LVEF before radiotherapy is below 59%
- Patients with congenital heart diseases, valvular diseases and arrhythmia
- Patients with pericardial effusion
- Patients receiving immunotherapy and drug targeted therapy
- Patients with a history of anthracycline use
Trial locations and contacts
No sites are listed yet.
Bing Lu contact
About this study
Official title: Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer Treated With Conventional Radiotherapy
Calculating which cardiac substructure accepting with the highest radiation dose by conventional radiotherapy, then to investigate the relationship between the changes of global longitudinal strain or cardiac magnetic resonance imaging and cardiac biomarkers and the certain cardiac substructure for stage N2-3 non-small cell lung cancer
Read the detailed description
All patients receive intensity-modulated radiotherapy (IMRT). The prescription dose of PTV is 60-70Gy，Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are detected before radiotherapy, at the end of radiotherapy (day 15), at the end of radiotherapy and at 1 month after radiotherapy. Echocardiography was performed before radiotherapy, in the middle of radiotherapy (day 15) and at the end of radiotherapy to obtain global longitudinal strain value. Cardiac magnetic resonance imaging is used to measure the blood flow of the anterior descending coronary artery before and at the end of radiotherapy.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imagingOther
Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are detected for cardiac biomarkers;echocardiography and cardiac magnetic resonance imaging are used to measure the functions of heart and vessels.
| Study group | Role | What they receive |
|---|---|---|
| Patients with NSCLC | all stage N2-3 non-small cell lung cancer patients receive intensity-modulated radiotherapy (IMRT). The prescription dose of PTV is 60-70Gy. Receives: Other: Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP
These levels are measured with the Siemens ADVIA Centaur XP Immunoassay System, normal ranges of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are 0-0.03 ng/mL, 0-0.01 ng/mL, 0-0.04 ng/mL, 0-100 pg/mL, and 0-125pg/mL respectively
Measured: through study completion, an average of 1 year
Global longitudinal strain value
global longitudinal strain value is obtained by offline analysis of 2-dimensional Echocardiography, reduction of more than 15% in left ventricular systole suggests some degree of cardiotoxicity by European Society of Cardiology 2016
Measured: through study completion, an average of 1 year
The average flow velocity of the anterior descending coronary artery
obtained by phase contrast magnetic resonance arteriography of cardiac magnetic resonance imaging
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start28 Feb 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bing Lu, Study chair, Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252065
- Sponsor's protocol ID
- GuizhouMuu
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer Treated With Conventional Radiotherapy
- ClinicalTrials.gov ID
- NCT05252065
- Acronym / sponsor ID
- GuizhouMuu
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Feb 2022 (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.
Calculating which cardiac substructure accepting with the highest radiation dose by conventional radiotherapy, then to investigate the relationship between the changes of global longitudinal strain or cardiac magnetic resonance imaging and cardiac biomarkers and the certain cardiac substructure for stage N2-3 non-small cell lung cancer
Detailed description
All patients receive intensity-modulated radiotherapy (IMRT). The prescription dose of PTV is 60-70Gy，Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are detected before radiotherapy, at the end of radiotherapy (day 15), at the end of radiotherapy and at 1 month after radiotherapy. Echocardiography was performed before radiotherapy, in the middle of radiotherapy (day 15) and at the end of radiotherapy to obtain global longitudinal strain value. Cardiac magnetic resonance imaging is used to measure the blood flow of the anterior descending coronary artery before and at the end of radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with NSCLC | – | Other: Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imagingall stage N2-3 non-small cell lung cancer patients receive intensity-modulated radiotherapy (IMRT). The prescription dose of PTV is 60-70Gy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with stage N2-3 non-small cell lung cancerreceive intensity-modulated radiotherapy (IMRT) from Guizhou medical university affiliated cancer hospital.
Key inclusion criteria (7 listed)
- Patients at TNM stage N2-N3 NSCLC confirmed by histopathology or cytology using IASLC International TNM staging standard (8th edition)
- KPS score >80; Aged 18 to 75 year-old
- No contraindications to radiotherapy
- No history of heart disease before treatment
- Patients receiving intensity modulated radiation therapy (IMRT)
Key exclusion criteria (8 listed)
- Patients with pleural effusion
- Patients with serious medical illness or infection
- Patients with acute myocardial infarction within 6 months
- In patients with NYHA grade 3-4, baseline LVEF before radiotherapy is below 59%
- Patients with congenital heart diseases, valvular diseases and arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imagingTroponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are detected for cardiac biomarkers;echocardiography and cardiac magnetic resonance imaging are used to measure the functions of heart and vessels. | Other | Patients with NSCLC |
Primary outcome
Concentration of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP
Time frame: through study completion, an average of 1 year
These levels are measured with the Siemens ADVIA Centaur XP Immunoassay System, normal ranges of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are 0-0.03 ng/mL, 0-0.01 ng/mL, 0-0.04 ng/mL, 0-100 pg/mL, and 0-125pg/mL respectively
Global longitudinal strain value
Time frame: through study completion, an average of 1 year
global longitudinal strain value is obtained by offline analysis of 2-dimensional Echocardiography, reduction of more than 15% in left ventricular systole suggests some degree of cardiotoxicity by European Society of Cardiology 2016
The average flow velocity of the anterior descending coronary artery
Time frame: through study completion, an average of 1 year
obtained by phase contrast magnetic resonance arteriography of cardiac magnetic resonance imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Bing Lu contact
Bing Lu study chair
Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Guizhou Medical University.
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 7 inclusion and 8 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 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Yiying Zhu (+8515989775891, 347454648@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 23 Feb 2022.