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: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 The objective of this study was to explore the association between human papillomavirus( HPV) and prognosis of lung cancer by meta-analysis. Methods The PubMed,Embase and Cochrane literature databases studies were searched using a combination of subject terms and free words. As of October 2018,a total of 123 related documents were obtained. After screen-ing the literature according to inclusion and exclusion criteria,the basic information of the study,HPV detection methods,lung cancer patients,hazard ratio(HR)values and 95% confidence interval(CI)were extracted from each study. The meta-analysis of random effects models was used to evaluate the correlation between HPV infection and prognosis in patients with lung cancer. Heterogeneity was assessed using the Q test and I2statistics,and publication bias was tested using Egger′s linear regression test and Begg′s rank cor-relation test. Results The study finally included 11 articles(9 in Asia,2 in Europe and US),and 1439 patients with lung cancer. Meta-analysis using a random-effects model showed no significant association between HPV infection and prognosis of lung cancer (HR=0. 90,95% CI:0. 71~1. 13). A stratified analysis of lung cancer pathological subtypes showed that the prognosis of patients with HPV-infected lung adenocarcinoma was significantly better than that in patients without HPV-infected lung adenocarcinoma (HR=0. 65,95% CI:0. 49~0. 85). Sensitivity analysis was performed by sequentially removing the included studies,and the results were not statistically significant. The results of Egger′s test(P=0. 708)and Begg′s test(P=0. 784)suggest that there is no publica-tion bias in this study. Conclusion HPV infection may be related to the prognostic of patients with lung adenocarcinoma. More basic and clinical studies are needed to further explore the association between HPV infection and lung adenocarcinoma as well as the corre-sponding mechanisms in the future.

Objective: To systematically review available risk prediction models evidence on construction and verification of colorectal cancer risk prediction models. Methods: "Colorectal neoplasms", "risk assessment", "colorectal cancer", "colorectal tumor", "colon cancer", "colon tumor", "rectal cancer", "rectal tumor", "anal cancer", "anal tumor", "risk prediction", "malignancy", "carcinogenesis", "model" were used as search keywords. Journal papers and grey literature were searched from Chinese electronic databases (CNKI and Wanfang) and English electronic databases (PubMed and Embase) from their inception to 30 Apr 2018. The language of literature was restricted to Chinese and English. The inclusion criteria were human-oriented researches with complete information for model construction,verification and evaluation. The exclusion criteria were informal publications such as conference abstracts, Chinese disertation papers, and non-primary research materials such as reviews,letters,and news reports. Descriptive characteristics,targeted population, study design, model construction method and prediction results were extracted. A total of 36 papers involving 27 models were included. The population characteristics of all included studies,the type of research, the method of model construction and the prediction results of the model were analyzed. Results: As for model construction,there were 13 European and American population based model studies,14 Asian population based model studies,including 7 Chinese mainland based model studies. According to the factors selected into the model, these models can be divided into traditional epidemiological models (17 models), clinical index combined models (4 models),and genetic susceptibility index combined models (6 models). As for model verification,only 9 models were cross-verified in the internal population after model construction, and the extrapolation of model prediction effect was not effectively evaluated; 17 models were verified in an external population; there was only one model verified in two external populations in terms of risk prediction effect; the area under the curve of 27 models was 0.56-0.85. Conclusion The risk prediction model of colorectal cancer is in the development stage. The external evaluation of model prediction effect is less and the prediction ability is not good, and the existing models have limited exploration of clinical indicators.

Objective: To investigate the association between tea consumption and lung cancer risk in Chinese males. Methods: Tea consumption and incident lung cancer cases were collected on a biennial basis among males in Kailuan Cohort during 2006-2015. Up to 31st December 2015, a total of 103 010 male candidates from the Chinese Kailuan Male Cohort Study were enrolled in the present study. Cox proportional hazards regression model was used to evaluate the association between tea consumption and risk of lung cancer in males. Results: The age of male candidates was (51.3±13.4)years old. There were 828 810.74 person-years of follow-up and 8.91 years of median follow-up period. During the follow-up, 964 lung cancer cases were identified. In male, the rate of never cosumers, tea drinkers (<4/week) and tea drinkers (≥4/week) were 58.17%(n=59 926), 24.04%(n=24 765) and 17.78%(n=18 319), respectively. After adjustment for potential confounding factors, HR (95%CI) of lung cancer for subjects with tea drinkers (<4/week) and tea drinkers (≥4/week) were 0.80 (0.63-1.02) and 1.02 (0.80-1.30), respectively, as compared with never cosumers. The results showed no significant association with lung cancer. Stratification analysis and sensitivity analysis showed no significant changes. Conclusion Our study has not found that tea consumption is significantly associated with the risk of male lung cancer.

Objective: To investigate the association between anthropometry and colorectal cancer risk in Chinese males. Methods: Anthropometry and incident colorectal cancer cases were collected on a biennial basis starting in May 2006 among males in Kailuan Cohort (2006-2014). In addition, electronic database of hospitals affiliated to Kailuan Community, Insurance System of Kailuan Community and Tangshan were also searched for supplementary information. Cox proportional hazards regression models and linear models were used to evaluate the association between baseline anthropometry and the risk of colorectal cancer in males. Results: A total of 106 786 males were included and 318 new colorectal cancer cases were identified in the Kailuan male cohort study, with 747 337.60 person-years follow-up by 31 December 2014. The median follow-up time was 7.90 years. Highest quartile waist circumference (≥94.0 cm) or WHtR (≥0.55) had 1.45 (95%CI: 1.05-2.02) and 1.66 (95%CI: 1.15-2.41) higher risk of colorectal cancer when compared with lowest waist circumference (<82.0 cm) or WHtR (<0.48) after adjusting for age, education, smoking, alcohol drinking, sitting time and dust exposure. Subgroup analyses by site indicated that males with BMI ≥26.27 kg/m², waist circumference ≥94.0 cm or WHtR ≥0.55 had HRs (95%CI) of 2.18(1.27-3.73), 2.20 (1.27-3.78) and 2.42 (1.29-4.56) for colon cancer risk, respectively. Linear models showed the HR of colon cancer and 95%CI would be 1.59 (1.24-2.02) with every 0.1 growth in WHtR. Conclusion Obesity may be responsible for an increased risk of colorectal cancer in male. Reasonable weight control may be one of the effective measures to prevent colorectal cancer.

Objective To investigate whether elevated levels of C?reactive protein ( CRP ) and neutrophil (NE) in the blood is associated with an increased risk of lung cancer incidence. Methods From 2006 to 2007, all employees and retirees from Kailuan (Group) Limited liability Corporation were included in this Kailuan Cohort study. The last follow?up date was December 2015. Data on new cases of lung cancer were collected, and multivariable Cox proportional hazards regression models were used to the relationship between baseline CRP and NE at baseline and risk of lung cancer. Results A total of 92 735 participants were enrolled in this study. During the follow?up, 850 new cases of lung cancer were identified. All subjects were divided into four groups according to the combination level of CRP and NE at baseline: CRP≤3 mg／L and NE≤4×109／L(Group A), CRP≤3 mg／L and NE＞4×109／L( Group B), CRP＞3 mg／L and NE≤4× 109／L(Group C), CRP＞3 mg／L and NE＞4×109／L(Group D). The cumulative incidence of lung cancer were 950／100 000, 1 030／100 000, 1 081／100 000 and 1 596／100 000 in these four groups, respectively (P＜0.001 ). Multivariate Cox proportional risk model showed that participants from Group D had an significantly increased 72% risks of lung cancer when compared to Group A ( 95% CI: 1.40～2.12, P＜0.001). Stratified analyses gender showed that males in Group D had higher risk of lung cancer when compared with participants in Group A (HR＝1.73, 95% CI: 1.40～2.15,P＜0.001).Conclusion Elevated levels of CRP and NE might increase the risk of lung cancer.

Objective To investigate whether elevated levels of C?reactive protein ( CRP ) and neutrophil (NE) in the blood is associated with an increased risk of lung cancer incidence. Methods From 2006 to 2007, all employees and retirees from Kailuan (Group) Limited liability Corporation were included in this Kailuan Cohort study. The last follow?up date was December 2015. Data on new cases of lung cancer were collected, and multivariable Cox proportional hazards regression models were used to the relationship between baseline CRP and NE at baseline and risk of lung cancer. Results A total of 92 735 participants were enrolled in this study. During the follow?up, 850 new cases of lung cancer were identified. All subjects were divided into four groups according to the combination level of CRP and NE at baseline: CRP≤3 mg／L and NE≤4×109／L(Group A), CRP≤3 mg／L and NE＞4×109／L( Group B), CRP＞3 mg／L and NE≤4× 109／L(Group C), CRP＞3 mg／L and NE＞4×109／L(Group D). The cumulative incidence of lung cancer were 950／100 000, 1 030／100 000, 1 081／100 000 and 1 596／100 000 in these four groups, respectively (P＜0.001 ). Multivariate Cox proportional risk model showed that participants from Group D had an significantly increased 72% risks of lung cancer when compared to Group A ( 95% CI: 1.40～2.12, P＜0.001). Stratified analyses gender showed that males in Group D had higher risk of lung cancer when compared with participants in Group A (HR＝1.73, 95% CI: 1.40～2.15,P＜0.001).Conclusion Elevated levels of CRP and NE might increase the risk of lung cancer.

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.