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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 *** multiple clinical trials over the past 25 years,POI has explored various aspects related to self-collection *** 2004–2006,POI established that self-collection could be equivalent to direct endocervical ***,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 *** 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 *** findings strongly support the integration of self-collection methodologies into cervical cancer control programs worldwide,particularly in medically underserved *** 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

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Evaluation of dry specimen transport and processing time using an isothermal amplification high-risk human papillomavirus assay

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Gynecology and Obstetrics Clinical Medicine 2022年第1期2卷 34-37页

作者： Longhua Hu Suhui Wu Haixia Shang jerome belinson Jinhong Li Xiaoqin Wu Yaling Huang Jingfen Sun Department of Obstetrics and Gynecology Shanxi Bethune HospitalShanxi Academy of Medical SciencesTongji Shanxi HospitalThird Hospital of Shanxi Medical UniversityTaiyuanShanxi ProvinceChina Department of Obstetrics and Gynecology Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei ProvinceChina Preventive Oncology International Inc. ClevelandOHUSA Women's Health Institute Cleveland ClinicClevelandOHUSA

Background:Dry specimen transport has shown equivalence to traditional liquid transport using a novel high-risk Human papillomavirus *** that dry transport might cross obstacles during cervical cancer screening in low and middle resource settings,this study was designed evaluate different processing time of dry specimen transport using the same isothermal amplification hrHPV ***:There were 564 women between the ages of 30–55 recruited from colposcopy *** each patient,two endocervical samples were collected and placed into empty collection tubes by *** were stored at room temperature until analyzed for hrHPV using the AmpFire assay at two time points:2 days and 2 weeks.511 of the 564 participants with positive hrHPV were provided colposcopy exam and quadrant ***:A total of 1128 endocervical samples from 564 patients were detected by the Ampfire *** agreement was found between two time periods(KappaStandard error=0.67±0.04).Sensitivity(2days/2weeks)for CIN2t was 95.28%(95%CI:92.14%–98.42%)vs 90.57%(CI(86.65%–94.49%)and specificity(2days/2weeks)was 22.47%(CI 19.33%–25.61%)vs 28.15%(CI 24.23%–32.07%)*** difference for Ampfire HPV detection in sensitivity for CIN2t for the two time periods was not significant(P=0.227),while the difference in specificity for CIN2t was significant(P=0.001).The difference in Ct values 29.23(CI 28.15–30.31)and 29.27(CI 28.19–30.35)between two time points was not significant(P?0.164).Conclusion:Processing dry brush specimens can be delayed up to 2 *** the AmpFire assay platform which supports cervical cancer prevention programs in low-to-middle-income countries(LMICs).

关键词： Cervical cancer Screening High-risk human papillomavirus Specimen transport Processing time Sample preparation

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Knowledge Concerning Hpv Vaccine In Chinese Women From Rural And Metropolitan Areas

Knowledge Concerning Hpv Vaccine In Chinese Women From Rural...

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24th International Papillomavirus Conference and Clinical Workshop

作者： Niyazi Mayinuer belinson jerome L The People’s Hospital of Xinjiang The Cleveland Clinic ClevelandOhioUSA

＜正＞Objective:To understand Chinese women’s knowledge concerning HPV infection and their attitude towards HPV vaccination So we could determine the feasibility of HPV vaccine in Chinese young women. Methods:This is a population-based *** study includes 3 rural sites of Shanxi,Xinjiang and Henan and 2 metropolitan

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Inappropriate Gold Standard Bias In Cervical Cancer Screening Studies

Inappropriate Gold Standard Bias In Cervical Cancer Screenin...

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24th International Papillomavirus Conference and Clinical Workshop

作者： Robert Pretorius jerome belinson Raoul Burchette Jennifer Smith Dept Ob/Gyn Southern California Permanente Medical Group-FontanaFontanaCA92335USA Dept Ob/GynThe Cleveland Clinic FoundationClevelandOH44195USA Dept.Research and Evaluation Southern California Permanente Medical GroupLosRoblesCAUSA Dept.Epidemiology Univ.North CarolinaChapelHillNC27599USA

＜正＞*** acid aided visual inspection（VIA）and colposcopic-directed biopsy both miss small ≥ cervical intraepithelial neoplasia（CIN） *** object of this review is to determine whether inflation of sensitivity of VIA occurs when colposcopic- directed biopsy is the gold standard for ≥ CIN 2. *** reviewed 375 women with ≥ CIN 2 from the Shanxi Province Cervical Cancer Screening Study Ⅱ.These women

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深圳自然人群HPV感染亚型及致癌性分析

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中国妇产科临床杂志 2019年第5期20卷 388-391页

作者：沈兢兢杜辉陈芸王纯张薇 jerome belinson 吴瑞芳北京大学深圳医院妇产科 518036 深圳女性重大疾病早期诊断技术重点实验室美国克利夫兰医学中心美国国际防癌组织

目的通过分析深圳地区自然人群HPV感染亚型,探讨不同基因型HPV的致癌性。方法以采用宫颈液基细胞学检查与飞行质谱(MALDI-TOF)HPV分型检测技术在深圳地区进行的人群为基础的宫颈癌筛查中高危型HPV阳性的1 574例妇女为研究对象,年龄25~5... 详细信息

目的通过分析深圳地区自然人群HPV感染亚型,探讨不同基因型HPV的致癌性。方法以采用宫颈液基细胞学检查与飞行质谱(MALDI-TOF)HPV分型检测技术在深圳地区进行的人群为基础的宫颈癌筛查中高危型HPV阳性的1 574例妇女为研究对象,年龄25~59岁、非妊娠期、未接受过子宫切除及盆腔放疗,所有研究对象均行阴道镜下四象限活检和宫颈管搔刮(ECC),病理诊断为金标准。结果 1 574例HPV阳性者中,随着病变级别增长,HPV-16、-18、-58三种亚型所占比率上升,HPV-52所占比率下降。分析检测出的CIN3及以上级别病变(CIN3^+)由高到低依次为HPV-16、-58、-18、-52,HPV-16亚型感染中CIN3^+占34.7%(105/303),HPV-58、-18、-52亚型感染中依次为20.7%(53/256)、17.5%(21/120),8.9%(41/460),其余亚型共检出CIN3^+4.49%,差异有统计学意义(P=0.000)。HPV-16、-18、-58三种亚型阳性者在 45岁三个年龄组所引起的高度病变均明显高于其余11种亚型阳性者,差异有统计学意义(P=0.000)。结论 HPV-16、-18、-58亚型感染者中CIN3^+病变比例高,其为高致癌性亚型;HPV-52在CIN3^+病变中比例低,其致癌性相对较弱。

关键词：人乳头瘤病毒亚型宫颈癌宫颈上皮内瘤变

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Constant Prevalence Of Human Papillomavirus Dna By Age In Five Distinct Geographical Areas Of China

Constant Prevalence Of Human Papillomavirus Dna By Age In Fi...

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24th International Papillomavirus Conference and Clinical Workshop

作者： Jennifer Smith jerome belinson Robert Pretorius Frank Taddeo Kia-Li Liaw UNC-Chapel Hill Cleveland Clinic SCPMG Fontana Merck＆Co. Inc. Merck＆Co. Inc.

＜正＞Background:Data on the disease burden of HPV infection,precursor CIN or invasive cervical cancer（ICC）are not available in many areas of China among reproductive-aged women. Objective:Evaluate the prevalence of HPV DNA and cervical disease in women from diverse geographical regions of China, stratified by age.

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北京社区妇女生殖道人乳头瘤病毒感染及子宫颈上皮内瘤变流行病学调查

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中华流行病学杂志 2007年第10期28卷 947-950页

作者：赵超李静屠铮宋丹崔淑慧章文华乔友林王建六 jerome belinson 魏丽惠北京大学人民医院妇科 100044 中国医学科学院肿瘤研究所 Cleveland Clinic Foundation USA

目的探讨北京市社区妇女中高危型人乳头瘤病毒(HPV)感染及子宫颈上皮内瘤变(CIN)状况。方法2006年6月至2007年6月对北京市展览路社区的795名20～54岁有性生活妇女进行筛查。筛查对象接受妇科检查时,依次留取超柏氏薄层液基细胞学(LCT)... 详细信息

目的探讨北京市社区妇女中高危型人乳头瘤病毒(HPV)感染及子宫颈上皮内瘤变(CIN)状况。方法2006年6月至2007年6月对北京市展览路社区的795名20～54岁有性生活妇女进行筛查。筛查对象接受妇科检查时,依次留取超柏氏薄层液基细胞学(LCT)和高危型HPV (hc2)检测标本,并对宫颈细胞学异常者行阴道镜检查及活检。结果795名社区妇女中高危型HPV感染阳性112例,占14.1%;阴性683例,占85.9%。高危型HPV感染率随宫颈病变加重,阳性率升高:正常宫颈及慢性宫颈炎人群为0.8%(6/751);CIN1为83.3%(10/12),CIN2及以上为100%(8/8);宫颈细胞学阳性并行阴道镜活检的40例中,发现11例慢性宫颈炎、14例宫颈湿疣、5例CIN1、3例CIN2、4例CIN3及1例早期浸润癌;细胞学阴性的750人中,发现2例宫颈湿疣、5例CIN1及1例宫颈低级别腺上皮内病变(CGIN)。750人中HPV阴性为669人,其中发现3例CINI及1例CGIN;HPV阳性为81例,其中2例CIN1及2例宫颈湿疣。在细胞学阳性(≥ASCUS)的40例中,HPV阴性为13例,其中发现10例慢性宫颈炎及3例宫颈湿疣;HPV阳性为27例,发现1例慢性宫颈炎、11例宫颈湿疣、7例CIN1、3例CIN2、4例CIN3及1例早期浸润癌,对宫颈病变的检出率后两者相比差异有统计学意义(P<0.001)。结论北京市社区妇女中高危型HPV感染率随子宫颈上皮内瘤变加重,阳性率升高。

关键词：生殖道人乳头瘤病毒感染子宫颈上皮内瘤变社区妇女北京市流行病学调查高危型人乳头瘤病毒薄层液基细胞学 HPV感染

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p16^INK4a免疫细胞化学染色在子宫颈癌筛查中的应用价值

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中华妇产科杂志 2020年第11期55卷 784-790页

作者：宋方彬杜辉肖爱民王纯黄霞阎培莎刘志红渠新风 jerome L belinson 吴瑞芳北京大学深圳医院妇产科深圳市女性重大疾病早期诊断技术重点实验室518036 Preventive Oncology International Cleveland HeightsOHUnited States of America44101

目的探讨p16^INK4a免疫细胞化学染色(p16^INK4a染色)作为新一代子宫颈细胞学检查技术在人群子宫颈癌初筛与辅助常规细胞学检查及高危型(HR)-HPV初筛后的二次筛查中的价值。方法募集2016—2018年深圳及周边地区25~65岁有性生活的非妊娠... 详细信息

目的探讨p16^INK4a免疫细胞化学染色(p16^INK4a染色)作为新一代子宫颈细胞学检查技术在人群子宫颈癌初筛与辅助常规细胞学检查及高危型(HR)-HPV初筛后的二次筛查中的价值。方法募集2016—2018年深圳及周边地区25~65岁有性生活的非妊娠期妇女5747例,采用HR-HPV联合子宫颈液基细胞学检查(LCT)进行子宫颈癌初筛;并行p16^INK4a染色,其中902例在初筛的同时进行p16^INK4a染色,其余4845例为HR-HPV与LCT初筛阳性回叫行阴道镜检查时取样进行p16^INK4a染色。将具有完整LCT检查、HR-HPV检测、p16^INK4a染色及子宫颈活检后病理诊断结果者纳入本研究。以组织学病理诊断为“金标准”,评价p16^INK4a染色作为子宫颈癌初筛、辅助LCT检查及HR-HPV初筛后的二次分流方案检出子宫颈病变[即高级别鳞状上皮内病变(HSIL)],包括HSIL[子宫颈上皮内瘤变(CIN)Ⅱ]及以上级别病变[HSIL(CINⅡ)+]、HSIL(CINⅢ)及以上级别病变[HSIL(CINⅢ)+]的筛查效率。结果(1)具有完整LCT检查、HR-HPV检测、p16^INK4a染色及子宫颈活检病理诊断结果者共1097例,纳入本研究。病理诊断:正常子宫颈995例,低级别鳞状上内病变(LSIL)37例、HSIL 64例及子宫颈癌1例,其中HSIL(CINⅡ)+65例,HSIL(CINⅢ)+34例。HSIL(CINⅡ)+患者的p16^INK4a阳性率(89.2%,58/65)显著高于CINⅠ或正常子宫颈者(10.2%,105/1032;P0.05),但其特异度均显著增高(82.5%与89.8%,80.2%与87.7%;P0.05)。(3)p16^INK4a染色辅助LCT检查:与单独LCT检查或HR-HPV检测辅助LCT检查比较,p16^INK4a染色辅助LCT检查检出HSIL(CINⅡ)+、HSIL(CINⅢ)+的特异度均显著增高(P0.05)。(4)p16^INK4a染色作为二次分流方案:HR-HPV初筛后以p16^INK4a阳性作为二次分流指标与LCT结果≥ASCUS作为二次分流指标比较,检出HSIL(CINⅡ)+、HSIL(CINⅢ)+的敏感度均无显著差异(84.6%与90.8%,88.2%与91.2%;P>0.05),而特异度均有显著差异(94.1%与89.7%,91.9%与87.4%;P<0.01);作为二次分流方案,HPV 16和(或)18型(HPV 16/18型)阳性与p16^INK4a阳性序贯的方案,HPV 16/18型阳性与LCT结果≥ASCUS序贯的方案,两种方案比较,检出HSIL(CINⅢ)+的敏感度无显著差异(分别为88.2%、94.1%,P=0.500),而前者的特异度显著增高(分别为88.3%、83.0%,P<0.01),且前者的阴道镜转诊率显著降低(分别为14.0%、19.4%,P=0.005)。结论p16^INK4a染色作为子宫颈癌初筛方案检出子宫颈病变的敏感度与HR-HPV检测相当、特异度与LCT检查相当;且在HR-HPV阳性患者的二次分流中具有优势,并可辅助LCT检查进行诊断分级,提高了子宫颈细胞学筛查的准确率。

关键词：宫颈肿瘤癌症早期检测宫颈上皮内瘤样病变周期素依赖激酶抑制剂p16 乳头状瘤病毒科免疫组织化学

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A Pilot Study to Evaluate an Internet-Based Cervical Cancer Screening Model Based on Self-Sampling

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Health 2016年第7期8卷 672-679页

作者： Ruifang Wu Xinfeng Qu Hui Du Zhihong Liu Qicai Hu Chun Wang Lijie Zhang Jinghui Zhao Guixang Wang jerome Leslie belinson Department of OB/GYN Peking University Shenzhen Hospital Shenzhen China Shenzhen Key Laboratory of Gynecological Diagnostic Technology Research Shenzhen China Preventive Oncology International Inc. Cleveland Heights USA Women Health Institute Cleveland Clinic Cleveland USA

Background: Community based cervical cancer screening models using self-collection can effectively place the identification of who is positive in the hands of the patient. The key areas we have identified as critical are 1) education, 2) notification of screening opportunities, 3) registration, 4) submission of samples, 5) receiving results with an explanation, and 6) being advised where to receive evaluation and management from qualified healthcare personnel. Methods: Our primary objectives were to create, register, and pilot a website as a public platform for cervical cancer prevention for both city and rural, individual and organizational application. We selected two sites: Shenzhen City in China as the local city (individual participant) site, and Sangzhi County in Hunan Province as the remote (group management) site. The website was reviewable to all of China, but applications for screening and registration were open only to the women from the 2 pilot sites. In the local site, the women would first sign up (obtain a password) to view the website (***), and then if they desired, they could register for screening using their true name and their state ID. After an offline confirmation of the address, the sampling kit would arrive. Results were available with additional education and guidance for care also on the website. Findings: 120,099 people nationwide visited the website in 27 months by the end of May, 2015, 1148 women from the sites registered at the website and 87.5% enrolled in the pilot trial. 72.3% of those testing positive returned for management. Virtually 100% of the registration/historical information was entered appropriately and 100% of the samples were handled properly. Interpretation: Web-based decision aids help patients through the uncertainties of healthcare. Applied to cervical cancer screening using self-collection, the effectiveness of the model specifically in respect to accessibility, education, registration, data input, and in

关键词： Cervical Cancer Internet Screening Self-Collection

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深圳市城乡女性人乳头瘤病毒感染相关因素调查

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中华流行病学杂志 2013年第8期34卷 796-799页

作者：梁凌云杜辉张薇陈芸吴波渠新风王纯杨斌吴若松 belinson jerome L 吴瑞芳北京大学深圳医院妇产科 518036 北京大学深圳医院超声科 518036 北京大学深圳医院皮肤科 518036 深圳市瑞安迪妇科门诊部美国克利夫兰医学中心病理科美国克利夫兰医学中心妇产科

目的研究城市和农村女性人乳头瘤病毒（HPv）感染相关因素的差异。方法2009—2010年对深圳市城乡10000名有性生活女性行HPV感染危险因素调查，并以3种方法检测人群HPV感染情况。结果总人群平均年龄38．9岁，HPV阳性率为33．3％，其中城... 详细信息

目的研究城市和农村女性人乳头瘤病毒（HPv）感染相关因素的差异。方法2009—2010年对深圳市城乡10000名有性生活女性行HPV感染危险因素调查，并以3种方法检测人群HPV感染情况。结果总人群平均年龄38．9岁，HPV阳性率为33．3％，其中城市（特区内、外）人群HPV阳性率分别为35．8％和30．2％，农村人群为33．8％。特区内人群HPV感染相关因素主要为人工流产史、多性伴及配偶长期外出；特区外人群HPV感染相关因素主要为多次人工流产、多性伴及使用避孕套避孕；农村人群HPV感染相关因素为多次人工流产和吸烟。结论城乡人群HPV感染相关因素具有差异。其中城市人群主要与多性伴相关，性生活使用避孕套有防护作用；吸烟对农村女性人群具有危险性；而多次人工流产为城乡女性人群HPV感染共同的危险因素。

关键词：人乳头瘤病毒感染相关因素城乡人群

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