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 systematically review the quality and reporting quality of colorectal cancer screening guidelines, and to provide reference for the update of colorectal cancer screening guidelines and colorectal cancer screening in China. Methods: "Colorectal cancer", "colorectal tumor", "screening", "screening", "guide", "consensus", "Colorectal cancer", "Colorectal neoplasms", "Screening", "Early Detection of Cancer", "Guideline" and "recommendation" were used as search keywords. The literature retrieval for all the Chinese and English guidelines published before April 2018 was conducted by using PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, China Biology Medicine disc (CBMdisc), Cochrane Library, Guideline International Network, China Guidelines Clearinghouse (CGC) and the official website of the US Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), International Agency for Research on Cancer (IARC), Australia Cancer Council (ACC) and Association of Coloproctology of Great Britain & Ireland (ACPGBI). The inclusion criteria were independent guidance documents for colorectal cancer screening. The language is limited to Chinese and English. The exclusion criteria were literature on interpretation, evaluation, introduction, etc., as well as the translated version of the guide and old guides. The quality and reporting norms of colorectal cancer screening guidelines were compared and evaluated using the European Guideline Research and Assessment Tool (AGREE Ⅱ) and the Practice Guideline Reporting Standard (RIGHT). Results: A total of 15 guides were included. The results of the AGREE Ⅱ quality evaluation showed that the overall quality of 15 guides was high. Among them, there were 9 guides with an overall score of 50 or more, 10 with a recommendation level of "A", and 2 with a rating of "B". There were 3 guides for "C"; each guide scores higher in scope and purpose, and clarity, and scores vary greatly in the areas of participants, rigor, applicability, and independence. The results of the RIGHT evaluation showed that 15 guides were insufficient in six areas except for background information, evidence, recommendations, reviews and quality assurance, funding and conflict of interest statements and management, and other aspects. Conclusion The overall quality of included guidelines for colorectal cancer screening is high, but the normative nature needs to be strengthened.

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.

Gastric cancer is one of the most common cancer. Studies have been conducted to evaluate the association between anthropometric indicators and gastric cancer, but the results were inconsistent. Therefore, a literature retrieval was conducted by using PubMed and Wanfang databases to summarize the latest research progress in the cohort study of the association between anthropometric indicators and the risk for gastric cancer. It was found that both general obesity and abdominal obesity might increase the risk for gastric cancer, while the association between underweight and gastric cancer needs further study. This paper summarizes the progress in the cohort study of association between anthropometric indicators for the risk for gastric cancer in order to provide evidence for the prevention and control of gastric 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.