Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: the ESTAMPA screening study protocol
Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: the ESTAMPA screening study protocol
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DOI：
10.1136/bmjopen-2019-035796
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发表时间：
2020-01-01
期刊：
影响因子：
2.9
通讯作者：
Herrero, Rolando
中科院分区：
文献类型：
--
作者：
Almonte, Maribel;Murillo, Raul;Herrero, Rolando
前言人乳头瘤病毒(HPV)检测正在取代细胞学在初筛中的地位。其有限的特异性要求使用第二次(分类)测试，以更好地识别宫颈疾病的高危女性。细胞学代表着直接的分类，但其低敏感性可能会阻碍HPV检测的敏感性，特别是在细胞学表现不佳的低收入和中等收入国家(LMIC)。ESTAMPA研究将：(1)评估不同的分诊技术在发现宫颈癌前病变方面的表现；(2)介绍如何在LMIC中实施基于HPV的筛查计划。方法和分析在拉丁美洲的12个研究中心，对30-岁的妇女进行HPV检测和PAP筛查。筛查阳性者行阴道镜检查，并进行病变活检和治疗。18个月后，没有明显疾病的妇女被召回进行另一次HPV检测；HPV阳性的妇女接受阴道镜检查，并根据需要进行活检和治疗。生物标本是在不同的访问中收集的，用于分类测试，不用于临床管理。这项研究的结果是组织学高度鳞状上皮内或更严重的损害(HSIL+)，在肛门下生殖器鳞状细胞术语下。将对大约50000名妇女进行筛查，发现500例HSIL+病例(在首次筛查和18个月筛查时)。将评估检测HSIL+的分类技术的性能指标(敏感度、特异度和预测值)，并与按年龄和研究中心进行的调整进行比较。伦理和传播研究方案已得到国际癌症研究机构(IARC)、泛美卫生组织(PAHO)的伦理委员会和每个参与中心的批准。已经成立了一个数据和安全监测委员会(DSMB)，以监测研究的进展，确保参与者的安全，就科学行为和分析提供建议，并提出协议改进建议。研究结果将发表在同行评议的期刊上，并在科学会议上发表。试验注册号NCT01881659
Introduction Human papillomavirus (HPV) testing is replacing cytology in primary screening. Its limited specificity demands using a second (triage) test to better identify women at high-risk of cervical disease. Cytology represents the immediate triage but its low sensitivity might hamper HPV testing sensitivity, particularly in low-income and middle-income countries (LMICs), where cytology performance has been suboptimal. The ESTAMPA (EStudio multicentrico de TAMizaje y triaje de cancer de cuello uterino con pruebas del virus del PApiloma humano; Spanish acronym) study will: (1) evaluate the performance of different triage techniques to detect cervical precancer and (2) inform on how to implement HPV-based screening programmes in LMIC.Methods and analysis Women aged 30-64 years are screened with HPV testing and Pap across 12 study centres in Latin America. Screened positives have colposcopy with biopsy and treatment of lesions. Women with no evident disease are recalled 18 months later for another HPV test; those HPV-positive undergo colposcopy with biopsy and treatment as needed. Biological specimens are collected in different visits for triage testing, which is not used for clinical management. The study outcome is histological high-grade squamous intraepithelial or worse lesions (HSIL+) under the lower anogenital squamous terminology. About 50000 women will be screened and 500 HSIL+ cases detected (at initial and 18 months screening). Performance measures (sensitivity, specificity and predictive values) of triage techniques to detect HSIL+ will be estimated and compared with adjustment by age and study centre.Ethics and dissemination The study protocol has been approved by the Ethics Committee of the International Agency for Research on Cancer (IARC), of the Pan American Health Organisation (PAHO) and by those in each participating centre. A Data and Safety Monitoring Board (DSMB) has been established to monitor progress of the study, assure participant safety, advice on scientific conduct and analysis and suggest protocol improvements. Study findings will be published in peer-reviewed journals and presented at scientific meetings.Trial registration numberNCT01881659