临床试验/NCT04305613

NCT04305613进行中（未招募）不适用

Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy: A Prospective Longitudinal Cohort

Abramson Cancer Center at Penn Medicine8 个研究点分布在 1 个国家目标入组 221 人开始时间: 2020年9月14日最近更新: 2025年10月2日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Abramson Cancer Center at Penn Medicine
入组人数: 221
试验地点: 8
主要终点: Growth Differentiation Factor 15

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This observational cohort will evaluate the cardiovascular effects of chemoradiation used to treat locally advanced, non-small cell lung cancer. Patients will be enrolled prior to the start of therapy and followed during and for at least 2 years after therapy with echocardiograms, nuclear stress tests, blood sampling, and quality of life surveys.

详细描述

Lung cancer is both the most common malignancy worldwide and the leading cause of cancer death in the US. While radiation therapy is highly effective for many solid tumors, thoracic radiation therapy carries a risk of cardiovascular morbidity and mortality that limits critical gains in cancer control and survival. The investigators will perform detailed cardiovascular phenotyping using biologic and imaging markers to define functional and physiologic perturbations that occur with radiation therapy. The study will provide insights into how cardiovascular risk factors and disease impact these biologic and functional changes. The investigators will also determine which radiotherapy dose-volume metrics are indicative of subclinical cardiotoxicity.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•At least 18 years of age
•Histologically confirmed or clinically diagnosed non-small cell lung cancer where the plan is for definitive treatment that includes radiation
•Able to give written informed consent

排除标准

•Pregnant or breast-feeding
•Prior treatment with anthracyclines
•Radiation treatment not expected to involve any heart exposure as determined by treating provider
•ECOG performance status greater than 2
•Vulnerable patients, including pregnant women and prisoners
•Contraindication to rest/vasodilator stress PET/CT, including: asthma with ongoing wheezing at time of enrollment; known Mobitz Type II AV block, 3rd degree AV block, or sick sinus syndrom, without a pacemaker; systolic blood pressure less than 90mmHg; known hypersensitivity to Regadenoson and adenosine; profound sinus bradycardia (heart rate less than 40bpm).

结局指标

主要结局

Growth Differentiation Factor 15

时间窗: up to 12 months

Change in GDF-15 from baseline

Coronary Flow Reserve (CFR_

时间窗: 6 months

Change in PET/CT derived CFR from baseline

Major Cardiovascular Events (2 Year)

时间窗: up to 24 months

Incidence of MCE assessed by EMR review and patient interview

Left Ventricular Strain

时间窗: up to 12 months

Change in echo-derived measures of LV peak systolic strain (longitudinal) from baseline

Ventricular Arterial Coupling

时间窗: up to 12 months

Change in echo-derived measures of ventricular-arterial coupling (Ea/Ees) from baseline

Cardiovascular Specific Mortality (2 Year)

时间窗: 24 Months

Cardiovascular specific mortality assessed by EMR review

High Sensitivity C-Reactive Protein

时间窗: up to 12 months

Change in hsCRP from baseline

Placental Growth Factor

时间窗: up to 12 months

Change in PIGF from baseline

Overall Survival (2 Year)

时间窗: 24 months

All-cause mortality assessed by electronic medical record (EMR) review

次要结局

High-Sensitivity Troponin T(up to 12 months)
N-type pro Brain Natriuretic Peptide(up to 12 months)
Right Ventricular Fractional Area Change (RAC)(up to 12 months)
Right Ventricular Longitudinal Strain(up to 12 months)
Circumferential Strain(up to 12 months)
Left Ventricular Ejection Fraction (2D)(up to 12 months)
Global and Regional Myocardial Blood Flow at Rest(up to 6 months)
FACIT Fatigue Score(up to 5 years)
Godin Leisure Time Exercise Score(up to 5 years)
Diastolic Function(up to 12 months)
Left Ventricular Ejection Fraction (3D)(up to 12 months)
Valvular Disease(up to 12 months)
Left Ventricular systolic strain (3D)(up to 12 months)
Left Ventricular Twist and Torsion(up to 12 months)
Global and Regional Myocardial Blood Flow at Stress(up to 6 months)
FACIT Dyspnea Score(up to 5 years)

研究者

发起方

Abramson Cancer Center at Penn Medicine

申办方类型

Other

责任方

Sponsor

研究点 (8)

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