Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer

NCT05252065 | Unknown

• 1 other identifier: GuizhouMuu
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 non-small cell lung cancer

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  through study completion, an average of 1 year

Study Arms (1)

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.

Other: Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging

Interventions

Cardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging OTHER

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.

Patients with NSCLC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with stage N2-3 non-small cell lung cancerreceive intensity-modulated radiotherapy (IMRT) from Guizhou medical university affiliated cancer hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guizhou Medical University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bing Lu

  Department of thoracic oncology, Affiliated Cancer Hospital of Guizhou Medical University

  STUDY CHAIR

Central Study Contacts

Yiying Zhu

CONTACT

+8515989775891; 347454648@qq.com

Bing Lu

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 23, 2022
• Study Start: February 28, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share