Objective:According to the international cooperation project of Peking University Cancer Hospital on human genetic resource management practices, combined with the development direction of human genetic resource management laws and regulations, and propose reference suggestions for medical institutions to strengthen human genetic resource management.Methods:Sort out the projects that Peking University Cancer Hospital obtained international cooperation approval on the government platform of the Ministry of Science and Technology from July 2019 to June 2023, analyze the current situation of human genetic resource management in the hospital, summarize the challenges brought by the implementation of new regulations on human genetic resource management in medical institutions, and propose corresponding suggestions.Results:A total of 1276 international cooperation projects on human genetic resources have been approved, including 345 initial declarations and 931 change declarations. Involving 453 studies, including 286 clinical trials of drugs or devices on the market, accounting for 63.13%, and 100 clinical trials of Phase I drugs, accounting for 34.97% of the market studies. On average, there are 3.14 changes per project for listed research, and 1.56 changes per project for non listed research.Conclusions:Regulations on the Management of Human Genetic Resources ( short for Rules) limit the management scope of international cooperation projects involving human genetic resources and delegate management authority to medical institutions. Adjusting the scope of application for international cooperative clinical trial filing may result in some administrative approval projects being transferred to filing. The approval process for international cooperative scientific research projects on human genetic resources has been adjusted. Suggest medical institutions to strengthen the management of samples and intellectual property outside the scope of application of Rules.Strengthen the entire process management of international cooperation in scientific research. Pay attention to and timely communicate the dynamics of human genetic resource management.

Objective:This paper aims to explore the management of human genetic resources in medical institutions, according to reflections of the management mode of a particular hospital, providing possible reference for other medical institutions.Methods:The management system of human genetic resources was constructed refer to the McKinsey 7S model. Approved projects information includes the types of projects, characteristics of human genetic resources involved and the characteristics of principal investigator are analyzed.Results:A total number of 82 projects were approved Since the implementation of newly updated Regulation of the People′s Republic of China on the Administration of Human Genetic Resources (hereinafter referred to as the regulations), and majority of which are drug clinical trials. The human genetic resources materials and data involved are mainly blood, urine, serum, plasma, clinical data, imaging data, etc. Most of the principal investigators with senior professional title are from key disciplines.Conclusions:McKinsey 7S model provides a new reference path for medical institutions to carry out human genetic resources management.

Objective:To evaluate the diagnostic performance of quantitative fecal immunochemical testing (FIT) and to provide reference for designing effective colorectal cancer (CRC) screening strategy in China.Methods:Based on an ongoing randomized controlled trial comparing the colorectal cancer screening strategies, this current study involved 3 407 participants aged 50-74 years who had undergone colonoscopies. All the feces samples were collected from the participants prior to receiving the colonoscopy. Fecal hemoglobin (Hb) was tested by FIT following a standardized operation process. Diagnosis-related indicators of FIT were calculated using the colonoscopy results as the gold standard.Results:Among the 3 407 participants, the mean age (SD) as 60.5 (6.3) years and 1 753 (51.5%) were males. The participants involved 28 (0.8%) CRCs, 255 (7.5%) advanced adenomas, 677 (19.9%) nonadvanced adenomas, and 2 447 (71.8%) benign or negative findings. With an overall positivity rate of 2.8% (96/3 407) at the recommended cutoff value of 20 μg Hb/g, the sensitivities of FIT for both CRC and advanced adenoma were 57.1% (95 %CI: 37.2%-75.5%) and 11.0% (95 %CI: 7.4%-15.5%), respectively, with the corresponding specificity as 98.4% (95 %CI: 97.8%-98.8%). At a decreased cut-off value of 5 μg Hb/g, the sensitivities for detecting CRC and advanced adenoma increased to 64.3% (95 %CI: 44.1%-81.4%) and 16.5% (95 %CI: 12.1%-21.6%), respectively, but the specificity reduced to 95.2% (95 %CI: 94.4%-95.9%). The areas under the ROC curve for CRC and advanced adenoma were 0.908 (95 %CI: 0.842-0.973) and 0.657 (95 %CI: 0.621-0.692), respectively. Of the diagnostic performance, there were no significant differences noticed by different sex and age groups. Conclusions:In our study, the quantitative FIT showed modest sensitivity in detecting CRC but limited sensitivity in detecting advanced adenoma. In population-based CRC screening programs, the quantitative FIT had the advantage of adjusting the positive threshold based on the targeted detection rate and available resource load of colonoscopy.

Objective:To systematically understand the global research progress in the construction and validation of lung cancer risk prediction models.Methods:"lung neoplasms" , "lung cancer" , "lung carcinoma" , "lung tumor" , "risk" , "malignancy" , "carcinogenesis" , "prediction" , "assessment" , "model" , "tool" , "score" , "paradigm" , and "algorithm" were used as search keywords. Original articles were systematically searched from Chinese databases (CNKI, and Wanfang) and English databases (PubMed, Embase, Cochrane, and Web of Science) published prior to December 2018. The language of studies was restricted to Chinese and English. The inclusion criteria were human oriented studies with complete information for model development, validation and evaluation. The exclusion criteria were informal publications such as conference abstracts, Chinese dissertation papers, and research materials such as reviews, letters, and news reports. A total of 33 papers involving 27 models were included. The population characteristics of all included studies, study design, predicting factors and the performance of models were analyzed and compared.Results:Among 27 models, the number of American-based, European-based and Asian-based model studies was 12, 6 and 9, respectively. In addition, there were 6 Chinese-based model studies. According to the factors fitted into the models, these studies could be divided into traditional epidemiological models (11 studies), clinical index models (6 studies), and genetic index models (10 studies). 15 models were not validated after construction or were cross-validated only in the internal population, and the extrapolation effect of models was not effectively evaluated; 8 models were validated in single external population; only 4 models were verified in multiple external populations (3-7); the area under the curve (AUC) of models ranged from 0.57 to 0.90.Conclusion:Research on risk prediction models for lung cancer is in development stage. In addition to the lack of external validation of existing models, the exploration of potential clinical indicators was also limited.

Objective:To investigate the association between metabolic syndrome (MS) components and renal cell cancer in Chinese males.Methods:All male employees and retirees of the Kailuan Group were recruited in the Chinese Kailuan Male Cohort Study. They had been experienced routine physical examinations ever two years since May 2006. A total of 104 274 males were prospectively observed by 31 December 2015. Information on demographics, height, weight, blood glucose, blood lipid, blood pressure, as well as the information of incident renal cell cancer cases were collected at the baseline investigation by questionnaire, physical measurement and laboratory test. Cox proportional hazards regression models were used to evaluate the association between baseline MS and MS components (body mass index, blood glucose, blood lipid, blood pressure) and the risk of renal cell cancer in males.Results:A total of 104 274 males were recruited in our study with a age of (51.21±13.46) years, with 823 892.96 person-years follow-up and the median follow-up time was 8.88 years. A total of 131 new renal cell cancer cases were identified in the Kailuan male cohort study, and the crude incidence density was 15.90 per 100,000 person-years. Compared with no MS, the hazard ratios ( HR) (95% CI) of MS was 1.97 (1.32-2.94).When compared with normal level, the HR (95% CI) of obesity or overweight, hypertension, and dyslipidemia was 1.49 (1.04-2.14), 1.56 (1.06-2.29), and 1.77(1.23-2.54), after adjusting for potential confounding factors (i.e., age, education, income, smoke, and alcohol drink), respectively. In addition, a statistically significant trend ( P for trend<0.001) of increased renal cell cancer risk with an increasing number of abnormal MS components was observed. Conclusion:Obesity or overweight, hypertension, dyslipidemia and MS may increase the risk of renal cell cancer for Chinese males.

Objective:To investigate the association between total cholesterol (TC) and primary liver cancer in Chinese males.Methods:Since May 2006, all the male workers, including the employees and the retirees in Kailuan Group were recruited in the Kailuan male dynamic cohort study. Information about demographics, medical history and TC levels was collected at the baseline interview, as well as information on newly-diagnosed primary liver cancer cases during the follow-up period. A total of 110 612 males were recruited in the cohort by 31 December 2015. TC levels were divided into four categories by quartile (<4.27, 4.27-4.90, 4.90-5.56 and ≥5.56 mmol/L), with the first quartile group serving as the referent category. Cox proportional hazards regression model was used to evaluate the association between TC levels and primary liver cancer risk.Results:By December 31, 2015, a follow-up of 861 711.45 person-years was made with a median follow-up period of 8.83 years. During the follow-up, 355 primary liver cancer cases were identified. Compared with the first quartile, the HR of incident primary liver cancer among participants with the second, third and highest quartile TC levels were 0.76 (95% CI: 0.58-1.01), 0.59 (95% CI: 0.43-0.79), and 0.36 (95% CI: 0.25-0.52), respectively after adjusting for age, educational level, income level, smoking status, drinking status, body mass index, and HBsAg status ( P for trend<0.001). Subgroup analyses found that the association between TC levels and primary liver cancer was robust (all P for trend<0.05). The results didn’t change significantly after exclusion of newly-diagnosed cases within the first 2 years, males with history of cirrhosis or subjects who took antihyperlipidemic drugs, participants with higher TC levels had a lower risk of primary liver cancer (all P for trend<0.05) and HR(95% CI) of incident primary liver cancer among participants with the highest quartile TC levels were 0.41 (0.28-0.61), 0.36 (0.25-0.53) and 0.38 (0.26-0.54), respectively. Conslusion:In this large prospective study, we found that baseline TC levels were inversely associated with primary liver cancer risk, and low TC level might increase the risk of primary liver cancer.

Objective:To systematically understand the global research progress in the construction and validation of lung cancer risk prediction models.Methods:"lung neoplasms" , "lung cancer" , "lung carcinoma" , "lung tumor" , "risk" , "malignancy" , "carcinogenesis" , "prediction" , "assessment" , "model" , "tool" , "score" , "paradigm" , and "algorithm" were used as search keywords. Original articles were systematically searched from Chinese databases (CNKI, and Wanfang) and English databases (PubMed, Embase, Cochrane, and Web of Science) published prior to December 2018. The language of studies was restricted to Chinese and English. The inclusion criteria were human oriented studies with complete information for model development, validation and evaluation. The exclusion criteria were informal publications such as conference abstracts, Chinese dissertation papers, and research materials such as reviews, letters, and news reports. A total of 33 papers involving 27 models were included. The population characteristics of all included studies, study design, predicting factors and the performance of models were analyzed and compared.Results:Among 27 models, the number of American-based, European-based and Asian-based model studies was 12, 6 and 9, respectively. In addition, there were 6 Chinese-based model studies. According to the factors fitted into the models, these studies could be divided into traditional epidemiological models (11 studies), clinical index models (6 studies), and genetic index models (10 studies). 15 models were not validated after construction or were cross-validated only in the internal population, and the extrapolation effect of models was not effectively evaluated; 8 models were validated in single external population; only 4 models were verified in multiple external populations (3-7); the area under the curve (AUC) of models ranged from 0.57 to 0.90.Conclusion:Research on risk prediction models for lung cancer is in development stage. In addition to the lack of external validation of existing models, the exploration of potential clinical indicators was also limited.

Objective:To investigate the association between metabolic syndrome (MS) components and renal cell cancer in Chinese males.Methods:All male employees and retirees of the Kailuan Group were recruited in the Chinese Kailuan Male Cohort Study. They had been experienced routine physical examinations ever two years since May 2006. A total of 104 274 males were prospectively observed by 31 December 2015. Information on demographics, height, weight, blood glucose, blood lipid, blood pressure, as well as the information of incident renal cell cancer cases were collected at the baseline investigation by questionnaire, physical measurement and laboratory test. Cox proportional hazards regression models were used to evaluate the association between baseline MS and MS components (body mass index, blood glucose, blood lipid, blood pressure) and the risk of renal cell cancer in males.Results:A total of 104 274 males were recruited in our study with a age of (51.21±13.46) years, with 823 892.96 person-years follow-up and the median follow-up time was 8.88 years. A total of 131 new renal cell cancer cases were identified in the Kailuan male cohort study, and the crude incidence density was 15.90 per 100,000 person-years. Compared with no MS, the hazard ratios ( HR) (95% CI) of MS was 1.97 (1.32-2.94).When compared with normal level, the HR (95% CI) of obesity or overweight, hypertension, and dyslipidemia was 1.49 (1.04-2.14), 1.56 (1.06-2.29), and 1.77(1.23-2.54), after adjusting for potential confounding factors (i.e., age, education, income, smoke, and alcohol drink), respectively. In addition, a statistically significant trend ( P for trend<0.001) of increased renal cell cancer risk with an increasing number of abnormal MS components was observed. Conclusion:Obesity or overweight, hypertension, dyslipidemia and MS may increase the risk of renal cell cancer for Chinese males.

Objective:To investigate the association between total cholesterol (TC) and primary liver cancer in Chinese males.Methods:Since May 2006, all the male workers, including the employees and the retirees in Kailuan Group were recruited in the Kailuan male dynamic cohort study. Information about demographics, medical history and TC levels was collected at the baseline interview, as well as information on newly-diagnosed primary liver cancer cases during the follow-up period. A total of 110 612 males were recruited in the cohort by 31 December 2015. TC levels were divided into four categories by quartile (<4.27, 4.27-4.90, 4.90-5.56 and ≥5.56 mmol/L), with the first quartile group serving as the referent category. Cox proportional hazards regression model was used to evaluate the association between TC levels and primary liver cancer risk.Results:By December 31, 2015, a follow-up of 861 711.45 person-years was made with a median follow-up period of 8.83 years. During the follow-up, 355 primary liver cancer cases were identified. Compared with the first quartile, the HR of incident primary liver cancer among participants with the second, third and highest quartile TC levels were 0.76 (95% CI: 0.58-1.01), 0.59 (95% CI: 0.43-0.79), and 0.36 (95% CI: 0.25-0.52), respectively after adjusting for age, educational level, income level, smoking status, drinking status, body mass index, and HBsAg status ( P for trend<0.001). Subgroup analyses found that the association between TC levels and primary liver cancer was robust (all P for trend<0.05). The results didn’t change significantly after exclusion of newly-diagnosed cases within the first 2 years, males with history of cirrhosis or subjects who took antihyperlipidemic drugs, participants with higher TC levels had a lower risk of primary liver cancer (all P for trend<0.05) and HR(95% CI) of incident primary liver cancer among participants with the highest quartile TC levels were 0.41 (0.28-0.61), 0.36 (0.25-0.53) and 0.38 (0.26-0.54), respectively. Conslusion:In this large prospective study, we found that baseline TC levels were inversely associated with primary liver cancer risk, and low TC level might increase the risk of primary liver cancer.

Objective: To investigate the association between BMI and gastric cancer risk in Chinese males. Methods: Data on body weight, body height and incidence of gastric cancer were collected on a biennial basis in males in Kailuan Cohort during 2006-2015. In addition, electronic databases of hospitals affiliated to Kailuan Group, insurance system of Kailuan Group and medical insurance system of Tangshan were used for supplementary information. Males with normal body weight (18.5 kg/m²≤BMI<24.0 kg/m²) were used as controls. Cox proportional hazards regression model was used to evaluate the association between baseline BMI and the risk of gastric cancer in males through the calculations of hazard ratio and 95% confidence interval. Results: A total of 109 600 males were included and 272 new gastric cancer cases were identified in Kailuan male cohort study, with a follow-up of 860 399.79 person-years during 2006-2015. The median follow-up period was 8.8 years. When compared with normal weight, the hazard ratios (HR) of underweight (BMI≤18.5 kg/m²) for gastric cancer risk were 2.11 (95%CI: 1.23-3.62) after adjusting for potential confounding factors (age, education level, smoking status, alcohol drinking status, dust exposure, salty food intake, tea drinking status). However, overweight or obesity showed no significant association with gastric cancer risk. The stratified analyses based on age, education level, status on smoking, alcohol drinking, tea drinking and dust exposure indicated that underweight showed significant association with gastric cancer risk in those with older age, those with high education level, non-smokers, non-alcohol drinkers, non-tea drinkers and those with dust exposure. Conclusion Underweight might increase the risk of gastric cancer in males in China, and this positive association might be associated with age, education level, status on smoking, alcohol-drinking, tea-drink, and dust exposure.