On September 21, 2018, at the CSCO Conference in 2018, Professor Chen Lei of the National Hepatocellular Science Center announced the results of the pilot test of the PreCar (Prospective suRveillance for very Early hepatoCellular cARcinoma) project.
The data showed that in the case of 95% specificity, the sensitivity of liver cancer detection exceeded 90%; even if the specificity standard was set at 99%, the sensitivity reached 87%. Behind the figures means that this year, the National Hepatocellular Science Center/Shanghai Oriental Hepatobiliary Surgery Hospital, Guangzhou Nanfang Hospital and Herui Gene jointly led the dozens of clinical centers to participate in the largest and most abundant liver cancer screening research in China. The phased result of people's excitement.
Similar studies in the early industry were accustomed to setting the specificity level at 95%. According to the communication between the PreCar project team and the clinical front line, it is considered that the higher level of specificity for early screening and diagnosis of tumors is particularly important. In the case of the combination of the technology and the level of the Swiss gene itself, it was finally decided to raise the specificity standard to 99%.
The results of the pilot study showed that about 40% of early-onset tumors per 10,000 people could be detected in the study compared to the pre-industry level, while reducing false positive results by about 80%. This indicates that China's liver cancer early screening research has achieved a phased lead in the world. "This is a solid step in the early domestic liver cancer screening research." The project undertaker and Rui Gene General Manager Zhou Wei said.
The PreCar project was led by Prof. Wang Hongyang, Academician of the Chinese Academy of Engineering, Director of the National Hepatocellular Science Center, Deputy Chief of Infectious Diseases of the Ministry of Science and Technology, and Chairman of the Asia-Pacific Association of Liver Diseases, and Professor Hou Jinlin of Guangzhou Nanfang Hospital. The project has received strong support from the national multi-center, multi-hospital and multi-platform. At the same time, this is also the largest prospective cohort study project for liver cancer in China, and it is a model for the cooperation between the authoritative institutions for clinical basic research of liver cancer in China and the leading companies in tumor gene detection.
Note: Specificity is associated with false positives during screening. If 100 healthy people, 10 healthy people are misdiagnosed as positive, the specificity is 90%; sensitivity refers to the screening process. The detection rate, if 100 cancer patients, can detect 90, that is, the sensitivity is 90%.
1. More than 90% sensitivity at 95% high specificity, and will be improved in the future.
The PreCar pilot program enrolled 1,500 volunteers, including more than 500 liver cancer patients (HCC) and more than 1,000 non-tumor high-risk/healthy people. The project uses a multi-class BioMarker test to comprehensively detect plasma ctDNA site mutations, structural variation, apparent variation, exogenous genome integration, and expression level changes by experimental techniques such as cSMART, Home-Seq, and SNAPSHOT. A variety of indicators, including. By distinguishing the molecular characteristics of tumor/non-tumor populations, the project initially completed the evaluation of the classification characteristics of early liver cancer screening.
After obtaining the original data, researchers of Ruirui classify these indicators, and continuously optimize the analysis process through machine learning, big data synthesis, and search algorithms to determine stable characteristic index values. Then, based on the integrated analysis and cross-validation of multi-indicator data, an independent sample set was also used for verification, and it was finally determined that more than 90% sensitivity could be achieved with 95% specificity, while 99% specificity was achieved. , can still achieve a stable sensitivity of 87%.
China is a big country with liver disease. According to data released by the World Health Organization in 2014, Chinese patients account for more than 50% of the annual increase in liver cancer. This is an occult cancer, and most patients are advanced in the diagnosis of cancer.
For the treatment of tumors, early detection and early treatment are the guiding principles. Taking the clinical data of lung cancer as an example, the 5-year survival rate after I stage treatment can reach 80%, the 5-year survival rate of stage II can reach 60%, and the 5-year survival rate of stage III is 20% on average. If liver cancer is treated at an early stage, the 5-year survival rate can reach 80%.
Liu Jingfeng, dean of Mengchao Hepatobiliary Hospital of Fujian Medical University who participated in the PreCar project, said: "By injection of preventive vaccine, the hepatitis B virus carrying rate has been greatly reduced in people under 45 years of age. However, the carrying rate is still high among people over 45 years old. This group of people is a high-risk group of liver cancer. At the same time, the number of liver cirrhosis and liver cancer caused by alcoholic liver and fatty liver is gradually increasing, and the situation of liver cancer prevention and control is severe."
“Every year, 2-3% of patients with cirrhosis are converted to liver cancer. The most important steps in liver cancer prevention are two steps. The first is prevention of untreated patients, and the second is regular screening in patients with liver disease. It can be discovered in the early stage of liver cancer," said Qian Yunsong, director of the cirrhosis department of Ningbo Second Hospital, a participant in the PreCar project.
"For many years, academics and clinics have been looking for effective diagnostic techniques for liver disease patients in China and for the prevention and treatment of liver diseases. It is hoped that through early tumor screening technology, early detection and early treatment will benefit patients and society. With high-throughput genes The detection technology is becoming more and more mature, giving us a new way to explore the method of early screening of cancer. Although the process will be full of challenges, it is an important direction for China and even the world to work together.†Academician of China Academy of Engineering, State Professor Wang Hongyang, director of the Center for Liver Cancer Science and co-founder of the PreCar project, said.
"Gene detection technology has developed rapidly in recent years. As an effective supplement to existing clinical detection techniques, it has opened up a new direction for some clinically difficult old problems such as early warning screening of cancer." Berry Gene Dr. Zhou Daixing, the general manager and director of Rui Gene, said, “We have a scientific and serious attitude towards early diagnosis and early screening of the tumor, and we have full confidence in our own technology. With the iterative upgrade of the algorithm, the screening results we get will be more accurate. ."
2. The pilot test lays a solid foundation for the prospective cohort study of 10,000 people.
The initial success of the pilot test established a multi-omics experimental protocol for the early genetic screening of the Swiss gene. At the same time, this also explores the integrated analysis algorithm for multi-category indicators. But this is only the first step in the early warning of tumors with the Swiss gene.
The PreCar project is regarded as an important milestone in the early diagnosis of early liver cancer screening in China. Prof. Chen Lei, researcher and general manager of the National Center for Liver Cancer Science, said, “In order to successfully carry out the PreCar project, it is a key link to determine early screening and screening of molecular markers and detection methods. The complexity of the tumor makes it rely on single molecular markers. The possibility of early screening is very low. The screening of multi-class molecular markers is also very challenging, not only to find suitable ones from a wide variety of markers, but also to establish a variety of reliable low-frequency detection techniques. The completion of pilot experiments, It confirms our research ideas and at the same time builds the experimental technology and analytical algorithm framework of the whole research."
“The establishment of the pre-technical system is very important for the implementation of large-scale forward-looking queues.†Mr. Zhou Wei said, “The whole research needs to be based on a relatively certain and stable technical condition, with sufficient preparation for pilot experiments, and a later perspective. The development of the cohort study has been smoother, and the analysis of clinical data can be deepened."
3, hyperscale prospective cohort study is the necessary path for tumor early diagnosis technology from laboratory to clinical transformation
The pilot study validated the possibility and reliability of early liver cancer screening, and the prospective study will follow up and observe the high-risk population for 3 years, and optimize the risk prediction model by using multi-point follow-up. Comprehensive performance indicators required for clinical practice.
The PreCar program will recruit more than 10,000 high-risk groups of liver cancer (including more than 5,000 patients with cirrhosis and more than 5,000 patients with hepatitis B), establish a follow-up monitoring cohort, and conduct a three-year prospective cohort study. Based on high-throughput genome sequencing technology, screening, identification and application of extremely early warning markers for peripheral blood cancer. The total investment of the project exceeds 100 million yuan, and most of it is undertaken by Herui Gene. It can be said that this project is a model for the cooperation between the authoritative institutions for clinical basic research of liver cancer in China and the leading enterprises in cancer gene detection in China.
"Because of the low incidence of cancer in the population and the complexity of its mechanism, leaving the ultra-large-scale prospective cohort study, early diagnosis and early screening of the tumor can not be discussed. Therefore, the establishment of a large-scale prospective cohort as soon as possible, early Screening research opportunities is a necessary condition for achieving early screening clinical landing," said Professor Chen Lei.
Mr. Zhou Wei also has the same view. "The early detection and early screening of genetic testing technology from the laboratory is only under the guidance of clinical experts. After a rigorous prospective and large-scale cohort verification, it proves that Scientific and clinical support, in order to achieve clinical product conversion."
The necessity of such large-scale population research has reached a consensus among domestic and foreign companies. Over the past few years, several representative companies in Europe and the United States have spent hundreds of millions of dollars on large-scale cohort trials. Chinese companies are expected to make full use of the advantages of domestic clinical resources to gain advantages in similar research.
4. There will be more early screening projects in the future.
“Screening, monitoring, and intervening the disease when the early tumor cells are not spreading is the most ideal clinical solution for the tumor. We decided to do this and discuss and demonstrate with many experts, which is what they have been In the direction of seeking. At the same time, we have also made a long-term technical reserve, and we are confident that we can help the clinical goal through technical means. The road to early screening of the tumor has many challenges, and it is fully prepared for the Swiss gene." Mr. Zhou Wei said.
This phased outcome demonstrates the potential for clinical application of Herrezyme's early liver cancer screening technology, and these results will be further validated in a prospective cohort study. The company also revealed that in the right time, they will gradually start service development and product conversion.
“Soon, we will have multiple tumor early diagnosis research projects,†added Mr. Zhou Wei.
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