NCT07465848招募中不适用
Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)12 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2025年10月8日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 12
- 主要终点
- To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer.
研究概览
简要总结
This research is a clinical performance study of in vitro diagnostic device (IVD), a prospective, multicentre, open-label, case-control clinical investigation aimed at constructing a predictive model that allows results to be classified as positive or negative in relation to the probability of having lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Case Group:
- •Person aged 45 years or older at the time of signing the consent form.
- •Person with a current anatomopathologically confirmed diagnosis of small-cell or non-small cell lung cancer.
- •Not having received any oncological treatment prior to sample collection (surgery, radiotherapy, or systemic treatment with chemotherapy or immunotherapy).
- •Control Group:
- •Cohort A (High risk controls):
- •Person aged 45 years or older at the time of signing the consent form.
- •High risk of lung cancer, defined as having a smoking history of at least 20 pack-year and currently smoking or having quit within the past 15 years.
- •No diagnosis or suspicion of lung cancer. Asymptomatic individuals who have undergone a chest computed tomography (CT) scan for lung cancer screening within the 12 months prior to signing the informed consent and as part of routine clinical practice, with a LUNG-RADS score of 3 or lower, will be included.
- •Cohort B (Low-risk controls):
- •Person aged 45 years or older at the time of signing the consent form.
- •Without high risk of lung cancer according to the criteria defined in cohort A.
- •No diagnosis or suspicion of lung cancer.
排除标准
- •History of any malignant neoplasm, except for subjects with tumors in localized stages who have undergone radical treatment and have been disease-free for at least five years.
- •Patient diagnosed with lung cancer who has already started oncological treatment before sample collection.
- •Patient who has undergone a biopsy or any invasive procedure or minor surgery less than 48 hours ago.
- •Patient who has undergone major surgery less than 7 days ago.
- •Patient with severe chronic kidney disease, defined as a glomerular filtration rate below 15 ml/min.
- •Patient with severe liver disease, defined as Child-Pugh C.
- •Active infection, or treated less than 4 weeks ago.
- •Vulnerable population, for example, minors, prisoners, pregnant women, adults physically or mentally incapable of giving consent.
研究组 & 干预措施
Case Group
Other
干预措施: Blood sample collection for telomere biomarker analysis (Diagnostic Test)
Case Group
Other
干预措施: Telomere biomarker analysis (Diagnostic Test)
Control Group
Other
Cohort A (High Risk Control) and Cohort B (Low Risk Control)
干预措施: Blood sample collection for telomere biomarker analysis (Diagnostic Test)
Control Group
Other
Cohort A (High Risk Control) and Cohort B (Low Risk Control)
干预措施: Telomere biomarker analysis (Diagnostic Test)
结局指标
主要结局
To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer.
时间窗: At study enrollment
次要结局
- To evaluate the performance characteristics of the predictive algorithm, which combines clinical parameters and telomeric variables, in a cohort of cases and controls.(At study enrollment)
研究者
研究点 (12)
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