Definire Modelli Di Screening Personalizzati, Basati Sull'intelligenza Artificiale, Per La Prevenzione E La Diagnosi Precoce Del Cancro Del Colon-retto
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- To develop a predictive risk model useful in tailoring screening strategies for high-risk colorectal neoplasm (advanced adenoma/early stage cancer)
研究概览
简要总结
Colorectal cancer screening is based on the fecal occult blood test (FIT), which has low sensitivity for adenomatous polyps, based on the currently used cut-off. Risk factors such as obesity, diabetes, alcohol, and cigarette smoking are associated with the presence of high-risk neoplasia in the screening population. CADe systems appear to increase ADR in screening programs; however, uncertainty remains regarding their true effectiveness.
The study could provide the tools to:
- devise a personalized pathway of CRC screening so as to refer to colonoscopy (with CAD or without CAD depending on the results that will be obtained) those at high risk of carrying neoplasms amenable to removal or curative treatment;
- define risk categories for theoretical screening models giving the possibility of moving from the concept "one size fits all" to that of "personalized and precision prevention".
详细描述
Colorectal cancer (CRC) represents the third most commonly diagnosed cancer and the fourth leading cause of cancer death worldwide. It is estimated for the coming decades that there will be a significant and progressive increase in its incidence, reaching a threshold of about 2.2 million new cases in 2030 worldwide.
In 2022 in Italy, 48,100 new diagnoses of CRC were estimated compared to 43,702 in 2020 with an increase of 4400 cases in 2 years (Italian Medical Oncology Association IOM Report 2022 - the numbers of cancer in Italy). According to data from the Italian Association of Cancer Registries (AIRTUM), CRC is the second highest cancer incidence among both males (15% of all new cancers) and females (13%), preceded by prostate and breast cancer, respectively (AIOM Report 2022).
Numerous risk factors are associated with colorectal cancer incidence, some of them non-modifiable, such as age, environmental determinants, hereditary factors, individual genetic predisposition, and epigenetic alterations, and others modifiable, such as sedentary lifestyle, high-calorie and saturated-fat diet, and smoking, behaviors that are more common in high-income countries.
Regarding age, one of the non-modifiable risk factors, the likelihood of colorectal cancer diagnosis increases sharply after age 50: more than 90% of colorectal cancer cases occur in people aged 50 years or older.
Among modifiable risk factors, physical activity is strongly associated with a reduced risk of colon cancer. Studies show that more physically active people have a 25% lower risk of developing both proximal and distal colon cancers than less active people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 50-69 years who underwent the fecal occult blood screening program
- •Male and female sex
- •Positivity to fecal occult blood (FIT) on the immunochemical screening test (OC-Sensor);the cut-off for determination of test positivity is 20 micrograms HgB/gr of stool (cut-off used in our country).
- •Subjects who provided written consent to participate in the study.
排除标准
- •Subjects who do not understand the Italian language
- •Subjects with previous history of total colectomy or bowel resections
- •Subjects with colonoscopy performed in the previous 12 months
- •Subjects with contraindications to colonoscopy
- •Subjects who have contraindication to sedation or anesthesia
- •Subjects with a personal history of CRC
- •Subjects with hereditary gastrointestinal cancer syndrome: familial adenomatous polyposis (FAP), attenuated FAP, MutYH-associated polyposis, Lynch or Lynch-like syndrome, and serratus polyposis syndrome.
- •Subjects with inflammatory bowel disease (Crohn's disease, ulcerative colitis).
研究组 & 干预措施
Colonoscopy using artificial intelligence (experimental group)
Colonoscopy using artificial intelligence
干预措施: GI Genius (Device)
Traditional colonoscopy (control group)
Traditional colonoscopy
干预措施: Colonscope Olympus (Other)
结局指标
主要结局
To develop a predictive risk model useful in tailoring screening strategies for high-risk colorectal neoplasm (advanced adenoma/early stage cancer)
时间窗: From enrollment to the end of treatment at 18 months.
Adenoma Detection Rate (ADR, percentage of patients screened with at least 1 adenoma or carcinoma histologically proven) assessed following endoscopic examination and post-collection histopathological result in relation to risk factors.
次要结局
未报告次要终点