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"Chinese Stroke Journal" is a high-level academic journal of the medical profession headed by the Ministry of Science and Technology of the People's Republic of China, sponsored by the Chinese Institute of Science and Technology Information, and undertaken by the Chinese Stroke Society.
In order to strengthen the medical information exchange in the field of cerebrovascular diseases, improve the academic level of medicine, and serve the majority of medical technology and health workers, the "Chinese Journal of Stroke" and the Yimaitong platform jointly launched a series of columns-"Stroke "Miscellaneous" Talks".
This column selects the high-quality content related to stroke in each issue of the Chinese Journal of Stroke, adapts it, and publishes it on the "Yimaitong Neurology" public account.
We look forward to learning and discussing stroke-related diseases with you! This article is organized: Text/Tang Jiu (Chinese Stroke Journal) Note: This article has been officially authorized by the "Chinese Stroke Journal", please do not reprint without authorization.
The original source of the article: Lin Jinxi, Liang Xianhong, Li Shangzhi, et al.
Research on the construction standard of cerebrovascular disease biobank[J].
Chinese Journal of Stroke, 2021, 16(5): 449-456.
Literature download link: http: //www.
chinastroke.
org.
cn/CN/abstract/abstract3297.
shtml Review of previous issues ↓↓↓ Issue 1: Why is it said that playing games can cure cognitive impairment? This review tells you that cerebrovascular disease is the second leading cause of death worldwide, but it is also a preventable and curable disease.
However, almost all drugs that have proven effective for cerebrovascular diseases are monopolized by foreign companies, and our country's voice is low.
This current situation also reveals a problem: Although my country has sufficient disease resources, drug research and development in the field of cerebrovascular diseases is very weak.
In order to solve this problem, and to accelerate the rapid development of my country's cerebrovascular disease prediction, diagnosis, treatment, and new drug research and development, it is imperative to establish a high-quality biological sample library in the field of cerebrovascular disease.
At present, my country's biological sample bank has been launched one after another, but the level is different.
Problems such as non-uniform operation specifications, different quality standards, and inconsistent data formats are still bottlenecks in the development and utilization of many biological sample library resources.
So, how to build a high-quality biological sample library? Recently, Wang Yongjun's team from the Neurology Center of Beijing Tiantan Hospital, Capital Medical University, shared in our journal in detail the valuable experience in the construction of the Tiantan Hospital's biobank.
Preliminary preparations If you want to establish a high-quality biological sample bank, you must first understand what a biological sample bank is.
Biobank, also known as biobank, refers to the standardized collection, processing, storage, and application of samples of healthy and diseased organisms, as well as clinical, treatment, and follow-up related to these biological samples based on the principles of medical ethics and informed consent of patients The quality control, information management and application system of other materials.
The biobank integrates various molecular data derived from biological samples and comprehensive information on related clinical phenotypes, auxiliary examinations, and treatment outcomes.
It is of great significance for the development of human disease prediction, diagnosis, treatment, and research and development of new drugs.
After clarifying the concept, it is necessary to know what indicators should be used to guide the construction.
The author determined the following index system through a large number of literature review and expert consultation, reference to the construction of international standard documents, experimental research and resource sharing: ①Hardware indicators: the hardware facilities requirements for the construction of biological sample banks, such as environmental conditions, power supply, Equipment and facilities, information platform construction, etc.
②Clinical information indicators: epidemiological information, general data elements, specific disease data elements that should be collected in clinical research of cerebrovascular diseases ③Sample collection information indicators: biological samples that meet the needs of clinical research on cerebrovascular diseases Establishing a system for types, quantities, treatment methods, etc.
At present, as an important supporting platform for clinical research on cerebrovascular diseases, the Tiantan cerebrovascular disease biological sample bank has completed construction specifications, construction allocation and resource utilization under the premise of complying with relevant national laws and regulations.
Management system, quality management system, hardware investment and software development, etc.
Establishing the operation and management system of the cerebrovascular disease sample bank: The operation of the Tiantan cerebrovascular disease biological sample bank implements a team cooperation operation mechanism under the legal person responsibility system.
Under the supervision and guidance of the Academic Committee and Ethics Committee of Tiantan Hospital, the project execution team coordinates the operation and management mode of cooperation between various functional departments (mainly including clinical research departments and biological sample banks) to ensure the smooth progress of the project.
The clinical research department is responsible for the formulation of the clinical research plan, project implementation, clinical data collection, quality control and data management; the sample bank cooperates with the clinical research department to complete the specific implementation of the research project.
Establish a quality management system for cerebrovascular disease biobanks: refer to ISO9001 standards to establish a quality management system for cerebrovascular disease biobanks, including a sample bank quality manual, program files, standard operating procedures, and various forms and records.
The quality management system covers the full-cycle standard operating procedures of biological sample collection, processing, storage, disposal, and transfer, and more than 70 standard documents have been formed.
Through trial operation and modification and adjustment, the Tiantan Cerebrovascular Disease Biological Sample Bank has passed ISO9001 certification in 2019.
Click on the picture to see a clear big picture: Construction and configuration of the cerebrovascular disease biological sample library: In terms of hardware investment, the current phase of the Tiantan biological sample library covers an area of 200 m2.
The second phase expansion covers an area of 500 m2, with a maximum capacity of 140 ultra-low temperature refrigerator storage equipment, and is expected to be put into use in June 2021.
At present, nearly 100 sets of sample processing equipment, sample quality control equipment, sample preservation equipment, automatic whole blood dispensing equipment, and automatic nucleic acid extraction equipment have been put into use.
Click on the picture to see a clear big picture: In terms of software investment, the ultra-low temperature refrigerator has developed a cerebrovascular disease biological sample management software, through sample registration, spatial positioning, storage, storage, transfer, early warning, query, statistics and other functions.
Strict data management is carried out on the storage conditions and experimental data of each sample to ensure the integrity, authenticity, reliability and traceability of information resources (Figure 3).
At the same time, the cloud platform real-time monitoring of all cryopreservation equipment is implemented.
Temperature changes to ensure stable sample storage conditions. Click on the picture to see a clear big picture: Integration and output Since the establishment of the cerebrovascular disease biobank in October 2009, 22 clinical studies on cerebrovascular disease have been supported, and 105,000 biological samples of cerebrovascular disease cases have been collected, covering a variety of Biochemical samples, such as serum, plasma, white blood cells, DNA, etc.
, total more than 1.
04 million (Figure 4).
Click on the picture to see a clear big picture: In the Tiantan Cerebrovascular Disease Biological Sample Library, the relevant collection, processing, preservation and testing data of biological samples are fed back to the Big Data Center of the National Neurological Diseases Clinical Medicine Research Center.
Combined with the project clinical data collected by the cerebrovascular disease clinical research information collection platform, a comprehensive information integration resource for cerebrovascular disease clinical research is formed, which is used to carry out clinical and multi-omics research on cerebrovascular disease.
Using the research results of cerebrovascular diseases carried out with samples in the library, 15 SCI articles have been published in international academic journals such as JAMA, Neurology, and Stroke.
It has made important contributions to the formulation of individualized treatment plans for cerebrovascular diseases and the assessment of recurrence risk.
What is the good experience of Temple of Heaven? As a very heterogeneous clinical syndrome, cerebrovascular disease has great differences between different regions and different ethnic groups.
Therefore, it is necessary to develop an innovative drug clinical information and specimen resource database platform that is suitable for studying the genetic and metabolic characteristics of the population of cerebrovascular diseases in my country and based on etiological classification.
At present, many countries including my country have established biobanks based on stroke registration.
However, there are still many shortcomings in the biological sample banks of cerebrovascular diseases at home and abroad: ① Population heterogeneity: For example, ischemic stroke is a syndrome affected by multiple factors, and its correct classification is the basis for guiding standardized treatment.
Many previous studies did not consider the heterogeneous characteristics of the pathogenesis of different ischemic strokes, leading to unstable research results. ②Lack of a unified data collection system for clinical and scientific research information: In the past, biological sample banks were mostly set up for scientific research, but most of this collected information was designated by specific research, ignoring a large amount of clinical information, which reduced the value of further scientific research of the database; In addition, to collect data for scientific research only, special manpower and material resources must be invested, making it more difficult and costly to collect data, and it is difficult for data to grow naturally.
③Lack of a unified database that integrates clinical information, sample information, and image information: Many biological sample libraries currently fail to integrate clinical, sample, and image information organically, so there is a lack of data for further high-level research, such as the inability to integrate various clinical phenotypes.
Perform an effective association study with the genotype obtained from the corresponding specimen data.
In this study, the Tiantan cerebrovascular disease biobank was closely integrated with the clinical research data platform when it was created.
On the one hand, the clinical case system was used to integrate the method of collecting scientific research data, which not only made scientific research data collection easier for routine inclusion in clinical cases In the work, it is more important to provide detailed clinical diagnosis, treatment, follow-up process and other data for scientific research medical records, which greatly increases the value of the database.
At the same time, the Tiantan cerebrovascular disease biological sample bank is also based on standardized clinical data and biological sample collection management mechanism, strict quality control system and standard ultra-low temperature storage conditions, and establishes standard operations covering the full cycle of biological sample collection, processing, storage, disposal, and transportation.
The process has improved the collection and processing level of biological sample resources of each sub-center in the multi-center study of cerebrovascular disease, collected biological sample resources mainly based on multi-center research projects, promoted the development of multi-omics research of cerebrovascular disease, and promoted Scientific research output efficiency.
In 2020, the Tiantan Cerebrovascular Disease Biobank has been upgraded to a hospital-level biobank.
The author stated that the next step will be to further improve the operation of the quality management system, ensure the quality of samples, and promote the development of resources in accordance with my country's "General Requirements for the Quality and Capability of Biological Sample Banks" (GB/T37864-2019).
In order to strengthen the medical information exchange in the field of cerebrovascular diseases, improve the academic level of medicine, and serve the majority of medical technology and health workers, the "Chinese Journal of Stroke" and the Yimaitong platform jointly launched a series of columns-"Stroke "Miscellaneous" Talks".
This column selects the high-quality content related to stroke in each issue of the Chinese Journal of Stroke, adapts it, and publishes it on the "Yimaitong Neurology" public account.
We look forward to learning and discussing stroke-related diseases with you! This article is organized: Text/Tang Jiu (Chinese Stroke Journal) Note: This article has been officially authorized by the "Chinese Stroke Journal", please do not reprint without authorization.
The original source of the article: Lin Jinxi, Liang Xianhong, Li Shangzhi, et al.
Research on the construction standard of cerebrovascular disease biobank[J].
Chinese Journal of Stroke, 2021, 16(5): 449-456.
Literature download link: http: //www.
chinastroke.
org.
cn/CN/abstract/abstract3297.
shtml Review of previous issues ↓↓↓ Issue 1: Why is it said that playing games can cure cognitive impairment? This review tells you that cerebrovascular disease is the second leading cause of death worldwide, but it is also a preventable and curable disease.
However, almost all drugs that have proven effective for cerebrovascular diseases are monopolized by foreign companies, and our country's voice is low.
This current situation also reveals a problem: Although my country has sufficient disease resources, drug research and development in the field of cerebrovascular diseases is very weak.
In order to solve this problem, and to accelerate the rapid development of my country's cerebrovascular disease prediction, diagnosis, treatment, and new drug research and development, it is imperative to establish a high-quality biological sample library in the field of cerebrovascular disease.
At present, my country's biological sample bank has been launched one after another, but the level is different.
Problems such as non-uniform operation specifications, different quality standards, and inconsistent data formats are still bottlenecks in the development and utilization of many biological sample library resources.
So, how to build a high-quality biological sample library? Recently, Wang Yongjun's team from the Neurology Center of Beijing Tiantan Hospital, Capital Medical University, shared in our journal in detail the valuable experience in the construction of the Tiantan Hospital's biobank.
Preliminary preparations If you want to establish a high-quality biological sample bank, you must first understand what a biological sample bank is.
Biobank, also known as biobank, refers to the standardized collection, processing, storage, and application of samples of healthy and diseased organisms, as well as clinical, treatment, and follow-up related to these biological samples based on the principles of medical ethics and informed consent of patients The quality control, information management and application system of other materials.
The biobank integrates various molecular data derived from biological samples and comprehensive information on related clinical phenotypes, auxiliary examinations, and treatment outcomes.
It is of great significance for the development of human disease prediction, diagnosis, treatment, and research and development of new drugs.
After clarifying the concept, it is necessary to know what indicators should be used to guide the construction.
The author determined the following index system through a large number of literature review and expert consultation, reference to the construction of international standard documents, experimental research and resource sharing: ①Hardware indicators: the hardware facilities requirements for the construction of biological sample banks, such as environmental conditions, power supply, Equipment and facilities, information platform construction, etc.
②Clinical information indicators: epidemiological information, general data elements, specific disease data elements that should be collected in clinical research of cerebrovascular diseases ③Sample collection information indicators: biological samples that meet the needs of clinical research on cerebrovascular diseases Establishing a system for types, quantities, treatment methods, etc.
At present, as an important supporting platform for clinical research on cerebrovascular diseases, the Tiantan cerebrovascular disease biological sample bank has completed construction specifications, construction allocation and resource utilization under the premise of complying with relevant national laws and regulations.
Management system, quality management system, hardware investment and software development, etc.
Establishing the operation and management system of the cerebrovascular disease sample bank: The operation of the Tiantan cerebrovascular disease biological sample bank implements a team cooperation operation mechanism under the legal person responsibility system.
Under the supervision and guidance of the Academic Committee and Ethics Committee of Tiantan Hospital, the project execution team coordinates the operation and management mode of cooperation between various functional departments (mainly including clinical research departments and biological sample banks) to ensure the smooth progress of the project.
The clinical research department is responsible for the formulation of the clinical research plan, project implementation, clinical data collection, quality control and data management; the sample bank cooperates with the clinical research department to complete the specific implementation of the research project.
Establish a quality management system for cerebrovascular disease biobanks: refer to ISO9001 standards to establish a quality management system for cerebrovascular disease biobanks, including a sample bank quality manual, program files, standard operating procedures, and various forms and records.
The quality management system covers the full-cycle standard operating procedures of biological sample collection, processing, storage, disposal, and transfer, and more than 70 standard documents have been formed.
Through trial operation and modification and adjustment, the Tiantan Cerebrovascular Disease Biological Sample Bank has passed ISO9001 certification in 2019.
Click on the picture to see a clear big picture: Construction and configuration of the cerebrovascular disease biological sample library: In terms of hardware investment, the current phase of the Tiantan biological sample library covers an area of 200 m2.
The second phase expansion covers an area of 500 m2, with a maximum capacity of 140 ultra-low temperature refrigerator storage equipment, and is expected to be put into use in June 2021.
At present, nearly 100 sets of sample processing equipment, sample quality control equipment, sample preservation equipment, automatic whole blood dispensing equipment, and automatic nucleic acid extraction equipment have been put into use.
Click on the picture to see a clear big picture: In terms of software investment, the ultra-low temperature refrigerator has developed a cerebrovascular disease biological sample management software, through sample registration, spatial positioning, storage, storage, transfer, early warning, query, statistics and other functions.
Strict data management is carried out on the storage conditions and experimental data of each sample to ensure the integrity, authenticity, reliability and traceability of information resources (Figure 3).
At the same time, the cloud platform real-time monitoring of all cryopreservation equipment is implemented.
Temperature changes to ensure stable sample storage conditions. Click on the picture to see a clear big picture: Integration and output Since the establishment of the cerebrovascular disease biobank in October 2009, 22 clinical studies on cerebrovascular disease have been supported, and 105,000 biological samples of cerebrovascular disease cases have been collected, covering a variety of Biochemical samples, such as serum, plasma, white blood cells, DNA, etc.
, total more than 1.
04 million (Figure 4).
Click on the picture to see a clear big picture: In the Tiantan Cerebrovascular Disease Biological Sample Library, the relevant collection, processing, preservation and testing data of biological samples are fed back to the Big Data Center of the National Neurological Diseases Clinical Medicine Research Center.
Combined with the project clinical data collected by the cerebrovascular disease clinical research information collection platform, a comprehensive information integration resource for cerebrovascular disease clinical research is formed, which is used to carry out clinical and multi-omics research on cerebrovascular disease.
Using the research results of cerebrovascular diseases carried out with samples in the library, 15 SCI articles have been published in international academic journals such as JAMA, Neurology, and Stroke.
It has made important contributions to the formulation of individualized treatment plans for cerebrovascular diseases and the assessment of recurrence risk.
What is the good experience of Temple of Heaven? As a very heterogeneous clinical syndrome, cerebrovascular disease has great differences between different regions and different ethnic groups.
Therefore, it is necessary to develop an innovative drug clinical information and specimen resource database platform that is suitable for studying the genetic and metabolic characteristics of the population of cerebrovascular diseases in my country and based on etiological classification.
At present, many countries including my country have established biobanks based on stroke registration.
However, there are still many shortcomings in the biological sample banks of cerebrovascular diseases at home and abroad: ① Population heterogeneity: For example, ischemic stroke is a syndrome affected by multiple factors, and its correct classification is the basis for guiding standardized treatment.
Many previous studies did not consider the heterogeneous characteristics of the pathogenesis of different ischemic strokes, leading to unstable research results. ②Lack of a unified data collection system for clinical and scientific research information: In the past, biological sample banks were mostly set up for scientific research, but most of this collected information was designated by specific research, ignoring a large amount of clinical information, which reduced the value of further scientific research of the database; In addition, to collect data for scientific research only, special manpower and material resources must be invested, making it more difficult and costly to collect data, and it is difficult for data to grow naturally.
③Lack of a unified database that integrates clinical information, sample information, and image information: Many biological sample libraries currently fail to integrate clinical, sample, and image information organically, so there is a lack of data for further high-level research, such as the inability to integrate various clinical phenotypes.
Perform an effective association study with the genotype obtained from the corresponding specimen data.
In this study, the Tiantan cerebrovascular disease biobank was closely integrated with the clinical research data platform when it was created.
On the one hand, the clinical case system was used to integrate the method of collecting scientific research data, which not only made scientific research data collection easier for routine inclusion in clinical cases In the work, it is more important to provide detailed clinical diagnosis, treatment, follow-up process and other data for scientific research medical records, which greatly increases the value of the database.
At the same time, the Tiantan cerebrovascular disease biological sample bank is also based on standardized clinical data and biological sample collection management mechanism, strict quality control system and standard ultra-low temperature storage conditions, and establishes standard operations covering the full cycle of biological sample collection, processing, storage, disposal, and transportation.
The process has improved the collection and processing level of biological sample resources of each sub-center in the multi-center study of cerebrovascular disease, collected biological sample resources mainly based on multi-center research projects, promoted the development of multi-omics research of cerebrovascular disease, and promoted Scientific research output efficiency.
In 2020, the Tiantan Cerebrovascular Disease Biobank has been upgraded to a hospital-level biobank.
The author stated that the next step will be to further improve the operation of the quality management system, ensure the quality of samples, and promote the development of resources in accordance with my country's "General Requirements for the Quality and Capability of Biological Sample Banks" (GB/T37864-2019).
