ARtificial Intelligence for heAlth and Prevention of Smoking-related Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,840
- 试验地点
- 2
- 主要终点
- Creation of Artificial Intelligence (AI) algorithm
研究概览
简要总结
The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
详细描述
Interventional pilot study, single-center with additional procedures, such as completion of EORTC-QLQ-LC29, EORTC-QLQ-C30 questionnaires, motivational test, Fagestrom test, anamnestic questionnaire, spirometry, measurement of carbon monoxide, Low-dose spiral computed tomography without contrast medium, peripheral venous blood sampling for a volume of 20 ml.
The study has the main objective of traininig and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types.
The study considers patients with suspected diagnosis or with a dignosis of lung cancer, smokers and former smokers over 50 years of age at high risk of lung cancer and subjects enrolled in previous screening cohorts at this Institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
盲法说明
No blinding in this study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High-risk screening subjects
- •Inclusion Criteria:
- •Age >= 50 years old
- •Active smokers
- •Former smokers (from no more than 15 years)
- •Pack/year >20
- •Risk-prediction model from Prostate, Lung, Colorectal, and Ovarian study (PLCOm2012) >1.2%
- •Provision and signature of informed consent
排除标准
- •Previous or concurrent neoplastic disease, excluding skin cancers
- •Cognitive or other problems that could hinder the collection of informed consent
- •Severe pulmonary or extra pulmonary disease
- •Previous low-dose computed tomography (CT) scan in the past 12 months
- •Previous high-risk positive screening subjects
- •Inclusion Criteria:
- •Subjects enrolled in previous lung cancer screening with the presence of lung nodules >4 mm and candidate to additional computed tomography (CT)
- •Signed informed consent
- •Exclusion Criteria:
- •Previous high-risk negative screening subjects
- •Inclusion Criteria:
- •Subjects enrolled in previous lung cancer screening in this Institute with negative computed tomography (CT)
- •Signed informed consent
- •Exclusion Criteria:
- •Lung Cancer patients
- •Inclusion Criteria:
- •Patients with diagnosis or suspicious diagnosis of lung cancer candidate to surgical treatment or already submitted to it
- •Patients with diagnosis of lung cancer treated with surgical resection
- •Signed informed consent
- •Exclusion Criteria:
- •computed tomography (CT) scans not available at San Raffaele Hospital
- •Previous neoadjuvant treatment
结局指标
主要结局
Creation of Artificial Intelligence (AI) algorithm
时间窗: from enrollment to 48 months
To train and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types. AUC (Area Under the Curve) values, expressed as mean and standard deviation (SD), comparing the ability in detecting the presence of nodules and differentiating the malignancy or benignity of a radiologist versus an AI algorithm, both trained on the same patient group.
次要结局
- Multimodal program(from enrollment to 48 months)
研究者
Muriana Piergiorgio
Medical Doctor
Scientific Institute San Raffaele