MC250406 Feasibility Study: Automated Risk Stratification, Serial AI-Augmented Imaging, and Biobanking for Early Detection of Sporadic Pancreatic Cancer (AI-PACED)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recruitment yield (Feasibility)
研究概览
简要总结
This clinical trial studies a new screening program to improve the early detection of sporadic pancreatic cancer in individuals with a high risk of developing pancreatic cancer. Pancreatic cancer remains one of the deadliest solid tumors, characterized by a long phase without symptoms followed by rapid progression once clinically evident. Despite advancements in treatment, the survival rate for pancreatic cancer remains low. Research has helped to identify a subset of individuals with a markedly high short-term risk for developing pancreatic cancer, which includes adults aged 50 and older with glycemically-defined new-onset diabetes and an Enriching New-Onset Diabetes for Pancreatic Cancer (ENDPAC) score ≥ 3. However, current practice guidelines do not provide clear pathways for surveillance or early detection. The screening program in this trial combines repeated contrast-enhanced computed tomography (CT) scans using artificial intelligence (AI) and blood draws. Contrast-enhanced CT is an imaging technique which creates a series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine and a contrast agent is used to enhance the images. The images are then reviewed using AI, which may make it easier to spot cancer earlier on the CT scans than with the human eye. Studying samples of blood in the laboratory from high-risk individuals may help doctors understand more about why they may develop pancreatic cancer. This may be an effective way to screen high-risk individuals and improve the early detection of sporadic pancreatic 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
- Single (Outcomes Assessor)
盲法说明
All CT scans obtained under the study will be interpreted by qualified radiologists who are not part of the study team and are blinded to study objectives.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 and ≤ 85 years
- •Glycemically-defined new-onset diabetes (gNOD) with onset ≤ 180 days preceding enrollment
- •Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score ≥ 3, based on validated risk stratification models
- •Provide written or remote informed consent
排除标准
- •Prior diagnosis of pancreatic ductal adenocarcinoma (PDA)
- •Known hereditary cancer syndromes (e.g., BRCA1/2, Lynch syndrome, Peutz-Jeghers)
- •Prior history of pancreatic surgery
- •Pancreatic cyst surveillance at time of registration
- •Contraindications to contrast-enhanced CT imaging per standard clinical practice at time of registration
研究组 & 干预措施
Group A1 (CT, blood, EMR surveillance)
Patients undergo contrast-enhanced abdominal CT and blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.
干预措施: Biospecimen Collection (Procedure)
Group A1 (CT, blood, EMR surveillance)
Patients undergo contrast-enhanced abdominal CT and blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.
干预措施: Computed Tomography with Contrast (Procedure)
Group A1 (CT, blood, EMR surveillance)
Patients undergo contrast-enhanced abdominal CT and blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.
干预措施: Electronic Health Record Review (Other)
Group A2 (blood, EMR surveillance)
Patients undergo blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.
干预措施: Biospecimen Collection (Procedure)
Group A2 (blood, EMR surveillance)
Patients undergo blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.
干预措施: Electronic Health Record Review (Other)
Group B (EMR surveillance)
Patients undergo EMR surveillance for PDA diagnosis for up to 36 months.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Recruitment yield (Feasibility)
时间窗: Up to 3 years
Will assess the feasibility of protocol implementation as defined by recruitment yield (% of flagged high-risk individuals who consent). Descriptive statistics will be used to summarize feasibility endpoints.
Imaging adherence rates (Feasibility)
时间窗: Up to 3 years
Will assess the feasibility of protocol implementation as defined by imaging adherence rates (% completing 3 scheduled computed tomography scans). Descriptive statistics will be used to summarize feasibility endpoints.
Blood collection success rates (Feasibility)
时间窗: Up to 3 years
Will assess the feasibility of protocol implementation as defined by blood collection success rates (% completing 3 scheduled blood collections). Descriptive statistics will be used to summarize feasibility endpoints.
Completeness of electronic medical record (EMR)-based follow-up (Feasibility)
时间窗: Up to 3 years
Will assess the feasibility of protocol implementation as defined by completeness of EMR-based follow-up (% of participants with outcome ascertainment). Descriptive statistics will be used to summarize feasibility endpoints.
次要结局
- Proportion of PDAs diagnosed at stage 0/I(Up to 3 years)
- Rate and type of incidental findings requiring downstream evaluation(Up to 3 years)
- Time from glycemically-defined new-onset diabetes (gNOD) onset to pancreatic ductal adenocarcinoma (PDA) diagnosis(Up to 3 years)
- Artificial intelligence (AI)-detected imaging signatures and standard radiologist interpretations(Up to 3 years)