Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 419
- 试验地点
- 29
- 主要终点
- The primary objective is to verify that the investigational IVDSW can discriminate between results of patients with PaC and persons without PaC but at higher risk of this cancer disease due to their predispositions.
研究概览
简要总结
Software "Lipidica" is intended to be used for processing data generated by the in-house in vitro diagnostic medical device for lipidomic testing for the purpose of screening Pancreatic cancer (PaC) in the population at high risk of this cancer due to familial risk, selected gene mutations or hereditary pancreatic diseases.
The primary objective is to verify that the investigational IVDSW can discriminate between results of patients with Pancreatic cancer and persons without Pancreatic cancer but at higher risk of this cancer disease due to their predispositions.
Participants will:
- come to baseline and end of study visit for blood sampling and medical imaging
- some participant will undertake one more visit depending on their results on baseline
详细描述
Pancreatic cancer (PaC) is one of the cancer diseases with the worst prognosis, as mortality almost equals the incidence. In the Czech Republic, the incidence of pancreatic ductal adenocarcinoma (PDAC) has had a clear upward trend since the late 1970s, and in 2018, 21.9 new cases per 100,000 persons were reported.
PDAC is associated with a poor prognosis for several reasons. Due to the usual asymptomatic course or occurrence of only non-specific symptoms, it is usually detected in an advanced stage. Moreover, the diagnosis by standard methods can be difficult in the early stages, and investigators lack sensitive and specific tumor markers. The disease forms distant metastases rapidly, which creates a very short time interval for effective curative interventions. So far, PaC screening possibilities in the Czech Republic are limited to several academic research screening cohorts.
Five-year survival, regardless of clinical stage, is 7-9%. The resectable disease is detected in 10% of patients with a 5-year survival of 42%. Locally advanced unresectable disease is found in about 30% of patients with a 5-year survival of 12%, and metastatic disease is diagnosed in about 60% of patients with a 5-year survival of only approx. 3%.
PaC screening is not suitable for an unselected population. By contrast, it is vital for individuals with a high risk of developing this disease due to family history and/or genetic predispositions. Early diagnosis resulted in more curative resections and longer survival in this population thanks to the screening programs. First economic evaluations described the possible cost-effectiveness of screening high-risk individuals.
Changes in plasma lipid concentrations were reported in various cancer types (bladder, breast, colorectal, gastric, liver, kidney, lung, oesophageal, ovarian, prostate, thyroid, and pancreas). The altered plasma lipid profile may originate not only from tumor cells, tumor stroma, and apoptotic cells but also from an immune response.
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
- Single (Outcomes Assessor)
盲法说明
The laboratory personnel performing the lipidomic testing and using the investigated medical device software will be blinded to the allocation of the participants/ samples.
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
- •Age ≥ 18 years
- •Signed informed consent
- •Histologically confirmed diagnosis of resectable PaC
排除标准
- •History of any other cancer disease
- •Present incurable malignancy
- •Unfit for radical curative resection of the tumor
- •Vegan or vegetarian diet
- •Inclusion Criteria Arm2:
- •Age ≥ 18 years
- •Signed informed consent
- •High risk of PaC due to the presence of one of the following risk factors:
- •Family history of PaC (≥ 2 first-degree or second-degree relatives with PaC in the same family line)
- •Confirmed germline mutation of STK11 (LKB1) regardless of family history
- •Confirmed germline mutation of CDKN2A leading to the alteration of p16 regardless of family history
- •Confirmed germline mutation of APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 AND ≥ 1 first-degree or second-degree relative with PaC
- •Present hereditary pancreatitis (recurrent acute pancreatitis or chronic pancreatitis and confirmed germline mutation of PRSS1)
- •Person with a family history of PaC: > 50 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
- •Person with STK11 mutation: > 35 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
- •Person with CDKN2A mutation: > 40 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
- •Person with APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 mutation: > 45 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
- •Person with hereditary pancreatitis: > 40 years or 20 years after the 1st attack (whichever comes first)
- •Exclusion Criteria Arm 2:
- •Pregnancy of planning to conceive in the next 12 months
- •History of any cancer disease
- •Present incurable malignancy
- •Inability to undergo planned medical imaging or blood sampling
- •Vegan or vegetarian diet
结局指标
主要结局
The primary objective is to verify that the investigational IVDSW can discriminate between results of patients with PaC and persons without PaC but at higher risk of this cancer disease due to their predispositions.
时间窗: Interim analysis 1 year from first subject enrolled and through study completion (an average of 3 years)
The primary objective will be assessed using the following parameters: Diagnostic sensitivity The sensitivity is defined as the capacity to correctly detect confirmed positive samples of plasma from patient with PaC diagnosed with standard diagnostic methods. Diagnostic specificity The specificity is the ability to correctly classify samples of plasma from patient without PaC but at higher risk of the disease. The diagnosis of PaC will be excluded using standard diagnostic methods. Positive predictive value It is the ratio of patients with PaC truly diagnosed as positive to all those who had positive results (including healthy subjects who were incorrectly diagnosed as patients with PaC). Negative predictive value It is the ratio of subjects truly diagnosed as negative to all those who had negative results (including patients with PaC who were incorrectly diagnosed as healthy). Likelihood ratio and Expected values in normal and affected populations
The primary objective is to verify that the investigational IVDSW can discriminate between results of patients with PaC and persons without PaC but at higher risk of this cancer disease due to their predispositions.
时间窗: Interim analysis 1 year from first subject enrolled and through study completion (an average of 3 years)
The primary objective will be assessed using the following parameters: Diagnostic sensitivity The sensitivity is defined as the capacity to correctly detect confirmed positive samples of plasma from patient with PaC diagnosed with standard diagnostic methods. Diagnostic specificity The specificity is the ability to correctly classify samples of plasma from patient without PaC but at higher risk of the disease. The diagnosis of PaC will be excluded using standard diagnostic methods. Positive predictive value It is the ratio of patients with PaC truly diagnosed as positive to all those who had positive results (including healthy subjects who were incorrectly diagnosed as patients with PaC). Negative predictive value It is the ratio of subjects truly diagnosed as negative to all those who had negative results (including patients with PaC who were incorrectly diagnosed as healthy). Likelihood ratio and Expected values in normal and affected populations
次要结局
未报告次要终点