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Development and validation of a predictive model for endocervical curettage in patients referred for colposcopy:A multicenter retrospective diagnostic study in China

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Chinese Journal of Cancer Research 2022年第4期34卷 395-405页

作者： Peng Xue Bingrui Wei Samuel Seery Qing Li Zichen Ye Yu Jiang youlin qiao Department of Epidemiology and Biostatistics School of Population Medicine and Public HealthChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100730China Faculty of Health and Medicine Division of Health ResearchLancaster UniversityLancasterLA14YWUnited Kingdom Diagnosis and Treatment for Cervical Lesions Center Shenzhen Maternity and Child Healthcare HospitalShenzhen 518028China

Objective:This study aimed to develop a nomogram that can predict occult high-grade squamous intraepithelial lesions or worse(HSIL+)and determine the need for endocervical curettage(ECC)in patients referred for colposcopy.Methods:This retrospective multicenter study included 4,149 patients who were referred to any one of six tertiary hospitals in China for colposcopy between January 2020 and November 2021 because of abnormal screening results.ECC data were extracted from the medical records.Univariate and multivariate logistic regression analyses were performed to identify factors that could predict HSIL+on ECC.Patients were randomly assigned to a training set or to an internal validation set for performance and comparability testing.The model was externally validated and tested in patients from two additional hospitals.The nomogram was assessed in terms of discrimination and calibration and subjected to decision curve analysis.Results:HSIL+was found on ECC in 38.8%(n=388)of cases.Our predictive nomogram included age group,cytology,human papillomavirus(HPV)status,visibility of the cervix and colposcopic impression.The nomogram had good overall discrimination,which was internally validated[area under the receiver-operator characteristic(AUC),0.839;95%confidence interval(95%CI),0.773-0.904].In terms of external validation,the AUC was 0.843(95%CI,0.773-0.912)for the consecutive sample and 0.843(95%CI,0.783-0.902)for the comparative sample.Calibration analysis suggested good consistency between predicted and observed probabilities.Decision curve analysis suggested this nomogram would be clinically useful with almost the entire range of threshold probabilities.Conclusions:This internally and externally validated nomogram can be easily applied and incorporates multiple clinically relevant variables that can be used to identify patients with occult HSIL+who need ECC.

关键词： Cervical cancer colposcopy endocervical curettage nomogram

Estimation of economic burden throughout course of cervical squamous intraepithelial lesion and cervical cancer in China:A nationwide multicenter cross-sectional study

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Chinese Journal of Cancer Research 2023年第6期35卷 675-685页

作者： Hao Chen Xuelian Zhao Shangying Hu Tingting You Changfa Xia Meng Gao Mingjie Dong youlin qiao Fanghui Zhao Department of Cancer Epidemiology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Office of Cancer Screening National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China School of Population Medicine and Public Health Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100730China Center for Global Health School of Population Medicine and Public HealthChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100730China

Objective: Cervical squamous intraepithelial lesion(SIL) and cervical cancer are major threats to females' health and life in China, and we aimed to estimate the economic burden associated with their diagnosis and treatment.Methods: A nationwide multicenter, cross-sectional, hospital-based survey was conducted in 26 qualified hospitals across seven administrative regions of China. We investigated females who had been pathologically diagnosed with SIL and cervical cancer, and included five disease courses(“diagnosis”, “initial treatment”,“chemoradiotherapy”, “follow-up” and “recurrence/progression/metastasis”) to estimate the total costs. The median and interquartile range(IQR) of total costs(including direct medical, direct non-medical, and indirect costs), reimbursement rate by medical insurance, and catastrophic health expenditures in every clinical stage were calculated.Results: A total of 3,471 patients in different clinical stages were analyzed, including low-grade SIL(LSIL)(n=549), high-grade SIL(HSIL)(n=803), cervical cancer stage ⅠA(n=226), ⅠB(n=610), ⅡA(n=487), ⅡB(n=282), Ⅲ(n=452) and Ⅳ(n=62). In urban areas, the estimated total costs of LSIL and HSIL were $1,637.7(IQR:$956.4-$2,669.2) and $2,467.1(IQR:$1,579.1-$3,762.3), while in rural areas the costs were $459.0(IQR:$167.7-$1,330.3) and $1,230.5(IQR:$560.6-$2,104.5), respectively. For patients with cervical cancer stage ⅠA,ⅠB, ⅡA, ⅡB, and Ⅲ-Ⅳ, the total costs were $15,034.9(IQR:$11,083.4-$21,632.4), $19,438.6(IQR:$14,060.0-$26,505.9), $22,968.8(IQR:$16,068.8-$34,615.9), $26,936.0(IQR:$18,176.6-$41,386.0) and $27,332.6(IQR:$17,538.7-$44,897.0), respectively. Medical insurance covered 43%-55% of direct medical costs for cervical cancer patients, while the coverage for SIL patients was 19%-43%. For most cervical cancer patients, the expense was catastrophic, and the extent of catastrophic health expenditure was about twice large for rural patients than that for urban patients in each stage.Conclusions: The economic burden of SIL and cervical cancer in Chi

关键词： Squamous intraepithelial lesion cervical cancer economic burden medicare catastrophic health expenditures

Weight change and all-cause and cause-specific mortality: A 25-year follow-up study

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中华医学杂志(英文版) 2024年第10期137卷 2024 Jan 29页

作者： Yang Huan Wang Jianbing Wang Xiaokun Sun Wanyi Tong Chenyunhao Fan Jinhu qiao youlin Abnet Christian C. Department of Cancer Epidemiology National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China Department of Public Health Zhejiang University School of Medicine National Clinical Research Center for Children’s Health Hangzhou Zhejiang China Metabolic Epidemiology Branch Division of Cancer Epidemiology and Genetics National Cancer Institute Rockville MD USA

Background: Whether the dynamic weight change is an independent risk factor for mortality remains controversial. This study aimed to examine the association between weight change and risk of all-cause and cause-specific mortality based on the Linxian Nutrition Intervention Trial (NIT) cohort.Methods: Body weight of 21,028 healthy residents of Linxian, Henan province, aged 40-69 years was measured two times from 1986 to 1991. Outcome events were prospectively collected up to 2016. Weight maintenance group (weight change <2 kg) or stable normal weight group was treated as the reference. Cox proportional hazard model was performed to calculate hazard ratios (HRs) and 95% confidence intervals (95% CIs) to estimate the risk of mortality.Results: A total of 21,028 subjects were included in the final analysis. Compared with the weight maintenance group, subjects with weight loss ≥2 kg had an increased risk of death from all-cause (HRAll-cause = 1.14, 95% CI: 1.09-1.19,P <0.001), cancer (HRCancer = 1.12, 95% CI: 1.03-1.21,P = 0.009), and heart disease (HRHeart diseases = 1.21, 95% CI: 1.11-1.31,P <0.001), whereas subjects with weight gain ≥5 kg had 11% (HRCancer = 0.89, 95% CI: 0.79-0.99,P = 0.033) lower risk of cancer mortality and 23% higher risk of stroke mortality (HRStroke = 1.23,95% CI: 1.12-1.34,P <0.001). For the change of weight status, both going from overweight to normal weight and becoming underweight within 5 years could increase the risk of total death (HROverweight to normal = 1.18, 95% CI: 1.09-1.27; HRBecoming underweight = 1.35, 95% CI: 1.25-1.46) and cancer death (HROverweight to normal = 1.20, 95% CI: 1.04-1.39; HRBecoming underweight = 1.44, 95% CI: 1.24-1.67), while stable overweight could increase the risk of total death (HRStable overweight = 1.11, 95% CI: 1.05-1.17) and death from stroke (HRStable overweight = 1.44, 95% CI: 1.33-1.56). Interaction effects were observed between age and weight change on cancer mortality, as well as between baseline BMI and weight change on all-cause, heart disease,

关键词： Weight change All-cause mortality Cancer Stroke Heart diseases Body mass index

Preventive Oncology International:A brief history of HPV self-collected vaginal specimens for cervical cancer screening

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Gynecology and Obstetrics Clinical Medicine 2023年第3期3卷 144-148页

作者： Jerome L.Belinson Robert G.Pretorius Ruifang Wu youlin qiao Preventive Oncology International Inc.Women's Health InstituteCleveland ClinicUSA Department of Ob/Gyn Southern California Permanente GroupFontanaCAUSA Department of Ob/Gyn Peking University Shenzhen HospitalShenzhenChina School of Population Medicine and Public Health Chinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing100005PR China

Since 1998,Preventive Oncology International,Inc.(POI)has been at the forefront of studying human papillomavirus(HPV)self-collection for cervical cancer screening,with a significant focus in China.Through multiple clinical trials over the past 25 years,POI has explored various aspects related to self-collection methodologies.In 2004–2006,POI established that self-collection could be equivalent to direct endocervical samples.Subsequently,a large randomized trial involving 10,000 patients in 2010 further confirmed that self-collected vaginal specimens,tested for high-risk HPV(hrHPV)using a PCR-based assay with high analytic sensitivity,could effectively replace endocervical specimens with minimal loss of sensitivity and a slight decrease in specificity.Throughout the years,POI's research has encompassed several crucial topics,including patient acceptance,the development of new cost-effective,simpler,and faster assays,exploring different collection devices,devising efficient methods of specimen transport,and implementing population-based screening systems.The findings strongly support the integration of self-collection methodologies into cervical cancer control programs worldwide,particularly in medically underserved regions.As HPV self-collection continues to evolve,ongoing research and innovations are expected to play a pivotal role in achieving the global mission of combating cervical cancer.

关键词： Human papillomavirus(HPV) Self-collection Self-sampling Cervical cancer screening

Programmable endonuclease combined with isothermal polymerase amplification to selectively enrich for rare mutant allele fractions

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Chinese Chemical Letters 2022年第8期33卷 4126-4132页

作者： Junman Chen Tian Qiu Michael G.Mauk Zheng Su Yaguang Fan Dennis J.Yuan Qinghua Zhou youlin qiao Haim H.Bau Jianming Ying Jinzhao Song Key Laboratory of Clinical Laboratory Diagnostics(Ministry of Education) College of Laboratory MedicineChongqing Medical UniversityChongqing 400016China The Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital) Institute of Basic Medicine and Cancer(IBMC)Chinese Academy of SciencesHangzhou 310022China Department of Mechanical Engineering and Applied Mechanics University of PennsylvaniaPhiladelphiaPA 19104United States Department of Pathology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Center for Global Health School of Population Medicine and Public HealthChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100730China Tianjin Key Laboratory of Lung Cancer Metastasis and Tumor Microenvironment Tianjin Lung Cancer InstituteTianjin Medical University General HospitalTianjin 300052China Sichuan Lung Cancer Institute Sichuan Lung Cancer CenterWest China HospitalSichuan UniversityChengdu 610041China

Liquid biopsy is a highly promising method for non-invasive detection of tumor-associated nucleic acid fragments in body fluids but is challenged by the low abundance of nucleic acids of clinical interest and their sequence homology with the vast background of nucleic acids from healthy cells.Recently,programmable endonucleases such as clustered regularly interspaced short palindromic repeats(CRISPR)associated protein(Cas)and prokaryotic Argonautes have been successfully used to remove background nucleic acids and enrich mutant allele fractions,enabling their detection with deep next generation sequencing(NGS).However,the enrichment level achievable with these assays is limited by futile binding events and off-target cleavage.To overcome these shortcomings,we conceived a new assay(Programmable Enzyme-Assisted Selective Exponential Amplification,PASEA)that combines the cleavage of wild type alleles with concurrent polymerase amplification.While PASEA increases the numbers of both wild type and mutant alleles,the numbers of mutant alleles increase at much greater rates,allowing PASEA to achieve an unprecedented level of selective enrichment of targeted alleles.By combining CRISPR-Cas9 based cleavage with recombinase polymerase amplification,we converted samples with0.01%somatic mutant allele fractions(MAFs)to products with 70%MAFs in a single step within 20 min,enabling inexpensive,rapid genotyping with such as Sanger sequencers.Furthermore,PASEA's extraordinary efficiency facilitates sensitive real-time detection of somatic mutant alleles at the point of care with custom designed Exo-RPA probes.Real-time PASEA'performance was proved equivalent to clinical amplification refractory mutation system(ARMS)-PCR and NGS when testing over hundred cancer patients'samples.This strategy has the potential to reduce the cost and time of cancer screening and genotyping,and to enable targeted therapies in resource-limited settings.

关键词： Mutant allele enrichment Programmable endonuclease Liquid biopsy Mutation detection Point-of-care testing CRISPR-Cas9 Recombinase polymerase amplification Nucleic acid diagnostics

Cervical cancer: Epidemiology, risk factors and screening

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Chinese Journal of Cancer Research 2020年第6期32卷 720-728页

作者： Shaokai Zhang Huifeng Xu Luyao Zhang youlin qiao Department of Cancer Epidemiology Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer HospitalHenan Engineering Research Center of Cancer Prevention and ControlHenan International Joint Laboratory of Cancer PreventionZhengzhou 450008China Department of Epidemiology National Cancer CenterChinese Academy of Medical SciencesSchool of Population Medicine and Public HealthPeking Union Medical CollegeBeijing 100021China

Cervical cancer is one of the leading causes of cancer death among females worldwide and its behavior epidemiologically likes a venereal disease of low infectiousness. Early age at first intercourse and multiple sexual partners have been shown to exert strong effects on risk. The wide differences in the incidence among different countries also influenced by the introduction of screening. Although the general picture remains one of decreasing incidence and mortality, there are signs of an increasing cervical cancer risk probably due to changes in sexual behavior. Smoking and human papillomavirus(HPV) 16/18 are currently important issues in a concept of multifactorial, stepwise carcinogenesis at the cervix uteri. Therefore, society-based preventive and control measures, screening activities and HPV vaccination are recommended. Cervical cancer screening methods have evolved from cell morphology observation to molecular testing. High-risk HPV genotyping and liquid-based cytology are common methods which have been widely recommended and used worldwide. In future, accurate,cheap, fast and easy-to-use methods would be more popular. Artificial intelligence also shows to be promising in cervical cancer screening by integrating image recognition with big data technology. Meanwhile, China has achieved numerous breakthroughs in cervical cancer prevention and control which could be a great demonstration for other developing and resource-limited areas. In conclusion, although cervical cancer threatens female health, it could be the first cancer that would be eliminated by human beings with comprehensive preventive and control strategy.

关键词： Cervical cancer epidemiology risk factors screening

Guidelines for cervical cancer screening in China

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Gynecology and Obstetrics Clinical Medicine 2023年第4期3卷 189-194页

作者： Mingzhu Li Lihui Wei Long Sui Ding Ma Beihua Kong Xiaohua Wu Peng Wu youlin qiao Fanghui Zhao Linhong Wang Chinese Society for Colposcopy and Cervical Pathology of China Healthy Birth Science Association(CSCCP) China Chinese Society of Gynecologic Oncology Chinese Medical AssociationChina Chinese Gynecological Cancer Society(CGCS) China Branch of Women's Health Medicine of China International Exchange and Promotive Association for Medical and Health Care China National Cervical Cancer Prevention Consortium of Cancer Foundation of China China Branch of Cancer Prevention and Control Chinese Preventive Medicine AssociationChina Chinese Association for Maternal and Child Health Studies China Department of Obstetrics and Gynecology Peking University People's HospitalBeijingChina Diagnosis and Treatment Center of Cervical Disease Obstetrics&Gynecology Hospital of Fudan UniversityShanghaiChina Department of Obstetrics and Gynecology Tongji HospitalTongji Medical College of HUSTWuhanChina Department of Obstetrics and Gynecology Qilu Hospital of Shandong UniversityJinanChina Department of Gynecological Oncology Fudan University Shanghai Cancer CenterShanghaiChina Department of Cancer Epidemiology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina National Center for Chronic and Noncommunicable Disease Control and Prevention Chinese Center for Disease Control and PreventionBeijingChina Center for Global Health School of Population Medicine and Public HealthChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijingChina

In response to the incidence of cervical intraepithelial neoplasia and cervical cancer in China and global screening strategies,a collaborative effort was undertaken by seven Chinese medical associations to develop this guideline for cervical cancer screening.The guideline recommends high-risk human papillomavirus(hr-HPV)testing as the preferred method for primary screening,which should have been approved by authoritative institutions and clinically validated for primary screening.In areas without access to HPV testing,cytology can be used as an alternative.However,it is recommended to replace cytology with HPV-based screening as conditions permit.Cotesting(HPV testing in combination with cytology)is recommended for areas with sufficient medical resources,opportunistic screening populations,and partial special populations.The guideline recommends that individuals with a cervix initiate cervical cancer screening at the age 25 years and undergo HPV testing alone or cotesting every five years,or cytology alone every three years.Women over the age of 65 who have had documented adequate negative prior screening in the past may terminate screening.Corresponding screening programs are proposed for different special populations.The development of these guidelines is an important step in the effort to eliminate cervical cancer in China.

关键词： Cervical cancer Primary screening Cervical cytology HPV testing Guideline

A study on service capacity of primary medical and health institutions for cervical cancer screening in urban and rural areas in China

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Chinese Journal of Cancer Research 2019年第5期31卷 838-848页

作者： Yang Li Li Ma Chunxia Yang Zhangya Chen Yuqian Zhao Le Dang Jinghe Lang youlin qiao Department of Epidemiology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Division of Health Information Dissemination Institute of Medical InformationChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100005China Department of Epidemiology Dalian Medical UniversityDalian 116027China Department of Epidemiology and Biostatistics West China School of Public Health and West fourth HospitalSichuan UniversityChengdu 610041China Executive office Taiyuan Health SupervisionTaiyuan 030001China Office of Cancer Prevention and Treatment Sichuan Cancer Hospital&InstituteSichuan Cancer CenterSchool of MedicineUniversity of Electronic Science&Technology of ChinaChengdu 610041China Department of Obstetrics and Gynecology Peking Union Medical College HospitalChinese Academy of Medical Sciences/Peking Union Medical College(CAMS/PUMC)Beijing 100730China

Objective: To provide a decision-making basis for sustainable and effective development of cervical cancer screening.Methods: This cross-sectional study assesses the service capacity to conduct cervical cancer screening with a sample of 310 medical staff, medical institutions and affiliated township health centers from 20 countylevel/district-level areas in 14 Chinese provinces in 2016.Results: The county-level/district-level institutions were the main prescreening institutions for cervical cancer screening. More medical staff have become engaged in screening, with a significantly higher amounts in urban than in rural areas(P<0.05). The number of human papillomavirus(HPV) testers grew the fastest(by 225% in urban and 125% in rural areas) over the course of the project. HPV testing took less time than cytology to complete the same number of screening tasks in both urban and rural areas. The proportion of mid-level professionals was the highest among the medical staff, 40.0% in urban and 44.7% in rural areas(P=0.406), and most medical staff had a Bachelor’s degree, accounting for 76.3% in urban and 52.0% in rural areas(P<0.001). In urban areas, 75.0% were qualified medical staff, compared with 68.0% in rural areas, among which the lowest proportion was observed for rural cytology inspectors(22.7%). The medical equipment for cervical pathology diagnosis in urban areas was better(P<0.001). HPV testing equipment was relatively adequate(typing test equipment was 70% in urban areas, and non-typing testing equipment was 70% in rural areas).Conclusions: The service capacity of cervical cancer screening is insufficient for the health needs of the Chinese population. HPV testing might be an optimal choice to fill the needs of cervical cancer screening given current Chinese medical health service capacity.

关键词： China cervical cancer screening health service capacity appropriate technology cytology testing HPV testing

Value of multi-quadrants biopsy:Pooled analysis of 11 population-based cervical cancer screening studies

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Chinese Journal of Cancer Research 2020年第3期32卷 383-394页

作者： Yuqian Zhao Fanghui Zhao Shangying Hu Xun Zhang Wenhua Zhang Qinjing Pan Julia C Gage Rengaswamy Sankaranarayanan youlin qiao Department of Cancer Epidemiology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Research Center of Cancer Prevention Sichuan Cancer Hospital&InstituteSichuan Cancer CenterSchool of MedicineUniversity of Electronic Science and Technology of ChinaChengdu 610041China Department of Pathology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Department of Gynaecology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Division of Cancer Epidemiology and Genetics National Cancer InstituteRockville 20852USA Research Triangle Institute Global India New Delhi 110019India Screening Group Section of Early Detection and PreventionInternational Agency for Research on CancerLyon 69372France

Objective:The accuracy of colposcopy-guided biopsy is key to the success of colposcopic triage in cervical cancer screening programs.However,there is no widely adopted biopsy guideline up to date.Our study aimed to determine whether multi-quadrants biopsy improves the yield of cervical lesions.Methods:Eleven population-based cervical cancer screening studies were conducted in China.Cytology,highrisk human papillomavirus(hrHPV)testing and visual inspection were performed for primary screening.Females positive on one or more tests were referred for colposcopy and biopsy.The proportion of detected cervical intraepithelial neoplasia(CIN)2+and yields by quadrant lesion-targeted biopsy or 4-quadrant random biopsy were compared.Results:Among 4,923 females included,1,606 had quadrant lesion-targeted biopsy,and 3,317 had 4-quadrant random biopsy.The cumulative CIN2+yield increased from 0.10 for only one quadrant-targeted biopsy to 0.21,0.34,and 0.58 for at most two,three and four quadrants targeted biopsies.Among hrHPV positive females with high-grade squamous intraepithelial lesion(HSIL)+cytology,the cumulative CIN2+yield of a second targeted biopsy in another quadrant was significantly increased(P<0.05).Among hrHPV-negative females,the yield of 4-quadrant random biopsies was 0.005,and the yield by lesion-targeted biopsies was 0.017.For hrHPV positive females who had 4-quadrant random biopsy,the additional CIN2+yield for HSIL+,low-grade squamous intraepithelial lesion(LSIL)cytology,or abnormal visual inspection via acetic acid and Lugol’s iodine(VIA/VILI)were 0.46,0.11,0.14.Conclusions:A 4-quadrant random biopsy is recommended only for hrHPV positive females with HSIL cytology,and is acceptable if hrHPV positive with LSIL cytology or with abnormal VIA/VILI.Our findings add evidences for an objective and practical biopsy standard to guide colposcopy in cervical cancer screening programs in low-and middle-income countries.

关键词： Cervical cancer and precancerous lesion colposcopy low-and middle-income countries multi-quadrant biopsy screening