Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)-Study protocol.
Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)-Study protocol.
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对艾滋病毒（Compass-dust）研究方案的女性宫颈癌筛查的P16/KI-67双重染色技术的比较评估。
DOI：
10.1371/journal.pone.0278077
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发表时间：
2023
期刊：
影响因子：
3.7
通讯作者：
Berek, Jonathan
中科院分区：
文献类型：
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作者：
Okunade, Kehinde C.;Badmos, Kabir Y.;Okoro, Austin A.;Ademuyiwa, Iyabo A.;Oshodi, Yusuf A.;Adejimi, Adebola;Awolola, Nicholas;Ozonu, Oluchi;Adelabu, Hameed S.;Olorunfemi, Gbenga A.;Akanmu, Alani I.;Banjo, Adekunbiola S.;Anorlu, Rose;Berek, Jonathan
感染HIV的妇女（WLHIV）从低度宫颈上皮内瘤变（CIN 1）进展为高度宫颈上皮内瘤变（CIN 2/3）的风险是HIV阴性妇女的3-5倍。有证据表明，目前的宫颈癌筛查方法在WLHIV中的效果较差。p16/Ki-67双染色技术（DUST）是一种安全、快速、敏感性和特异性均较高的CIN 2/3筛查方法。本方案中的研究将评价DUST在WLHIV人群中进行宫颈癌筛查的性能。我们将进行一项参与者内比较研究（1期），在尼日利亚拉各斯的两个经认可的成人艾滋病毒治疗中心招募n = 1，123名25-65岁的性活跃WLHIV患者，以比较DUST与目前使用的筛查方法（巴氏涂片、hr-HPV DNA或VIA检测）在检测高级别CIN和癌症（CIN 2+）方面的性能。随后，将进行一项前瞻性队列研究（II期），招募所有在I期诊断为低度CIN（CIN 1）的WLHIV患者，进行为期2年的6个月随访，以检测CIN 1至CIN 2+的持续性和进展。这项研究的结果可能提供证据的存在一个更好的性能筛选方法的主要和分诊检测CIN 2+在WLHIV。它还可以证明，这种高性能的测试可以通过延长评估之间的间隔来提高筛查的长期预测准确性，从而降低总体成本，增加筛查的吸收和随访的依从性。
The risk of progression of low-grade (CIN1) to high-grade cervical intraepithelial neoplasia (CIN2/3) is 3–5 times higher for women living with HIV (WLHIV) than for HIV-negative women. Evidence suggests that the current cervical cancer screening methods perform less effectively in WLHIV. An emerging screening method–p16/Ki-67 dual staining technology (DUST) is a safe and rapid assay that could be used to detect CIN2/3 with higher sensitivity and specificity. The study in this protocol will evaluate the performance of DUST in cervical cancer screening among WLHIV. We will conduct an intra-participant comparative study (Phase 1) to enrol n = 1,123 sexually active WLHIV aged 25–65 years at two accredited adult HIV treatment centres in Lagos, Nigeria to compare the performance of DUST to the currently used screening methods (Pap smear, hr-HPV DNA, or VIA testing) in detecting high-grade CIN and cancer (CIN2+). Subsequently, a prospective cohort study (Phase 2) will be conducted by enrolling all the WLHIV who are diagnosed as having low-grade CIN (CIN1) in Phase 1 for a 6-monthly follow-up for 2 years to detect the persistence and progression of CIN1 to CIN2+. The findings of this study may provide evidence of the existence of a better performance screening method for the primary and triage detection of CIN2+ in WLHIV. It may also demonstrate that this high-performance test can improve the long-term predictive accuracy of screening by extending the intervals between evaluations and thus decrease the overall cost and increase screening uptake and follow-up compliance in WLHIV.
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影响因子：
1.8
作者：
Loopik, Diede L.;Bekkers, Ruud L. M.;Bentley, James R.
通讯作者：
Bentley, James R.
DOI：
10.1097/00126334-200108150-00007
发表时间：
2001-08-15
期刊：
JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
影响因子：
--
作者：
Stein, MD;Cunningham, WE;Shapiro, MF
通讯作者：
Shapiro, MF
影响因子：
7
作者：
Sinharay, S;Stern, HS;Russell, D
通讯作者：
Russell, D
影响因子：
3.8
作者：
Chung, Michael H.;McKenzie, Kevin P.;Mugo, Nelly R.
通讯作者：
Mugo, Nelly R.
影响因子：
3.7
作者：
Firnhaber, Cynthia;Mayisela, Nomtha;Smith, Jennifer S.
通讯作者：
Smith, Jennifer S.