Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study.
Molecular markers of risk of subsequent invasive breast cancer in women with ductal carcinoma in situ: protocol for a population-based cohort study.
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DOI：
10.1136/bmjopen-2021-053397
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发表时间：
2021-10-26
期刊：
影响因子：
2.9
通讯作者：
Loudig O
中科院分区：
文献类型：
--
作者：
Rohan TE;Ginsberg M;Wang Y;Couch FJ;Feigelson HS;Greenlee RT;Honda S;Stark A;Chitale D;Wang T;Xue X;Oktay MH;Sparano JA;Loudig O
乳腺导管原位癌(DCIS)是浸润性乳腺癌(IBC)的非特异性先兆。许多DCIS患者要么治疗不足，要么治疗过度。这项研究的首要目标是促进发现有IBC发展风险的DCIS患者。在这里，我们建议使用风险因素数据和福尔马林固定的石蜡包埋组织(FFPE)，来自8175名首次诊断为DCI并随后进行IBC的大型、种族多样化的基于人群的 女性队列：识别/验证DCIS组织中miRNA表达的变化与后续IBC的风险；结合两个先前确定的标记物集(p16、COX-2、Ki67的三重免疫阳性；Onco型DX乳腺DCIS评分)评估同侧IBC的风险；检查风险因素数据与IBC风险的关联。我们正在进行一系列嵌套在队列中的病例对照研究。病例是患有DCIS的妇女，她们随后发生了IBC；对照(2例)与DCIS诊断时日历年和年龄的病例相匹配。我们预测了485例/970例对照，目的是关注危险因素。我们估计有320个病例/640个对照获得FFPE组织，目的是关注miRNAs；在这些病例中，173个病例/346个对照将被纳入关注p16、COX-2和Ki67免疫阳性的目标，而在后者中，156个病例-对照将被纳入关注Oncotype DX乳腺DCIS Score®的目标中。采用多元条件Logistic回归进行统计分析。伦理审查委员会获得了阿尔伯特·爱因斯坦医学院(IRB 2014-3611)、科罗拉多州Kaiser Permanente、Kaiser Permanente Hawaii、Henry Ford Health System、Mayo Clinic、Marshfield Clinic Research Institute和Hackensack Meridian Health的机构审查委员会以及寿命研究保护办公室的批准。研究结果将在会议上公布，并发表在同行评议的期刊上。
Ductal carcinoma in situ (DCIS) of the breast is a non-obligate precursor of invasive breast cancer (IBC). Many DCIS patients are either undertreated or overtreated. The overarching goal of the study described here is to facilitate detection of patients with DCIS at risk of IBC development. Here, we propose to use risk factor data and formalin-fixed paraffin-embedded (FFPE) DCIS tissue from a large, ethnically diverse, population-based cohort of 8175 women with a first diagnosis of DCIS and followed for subsequent IBC to: identify/validate miRNA expression changes in DCIS tissue associated with risk of subsequent IBC; evaluate ipsilateral IBC risk in association with two previously identified marker sets (triple immunopositivity for p16, COX-2, Ki67; Oncotype DX Breast DCIS score); examine the association of risk factor data with IBC risk. We are conducting a series of case–control studies nested within the cohort. Cases are women with DCIS who developed subsequent IBC; controls (2/case) are matched to cases on calendar year of and age at DCIS diagnosis. We project 485 cases/970 controls in the aim focused on risk factors. We estimate obtaining FFPE tissue for 320 cases/640 controls for the aim focused on miRNAs; of these, 173 cases/346 controls will be included in the aim focused on p16, COX-2 and Ki67 immunopositivity, and of the latter, 156 case–control pairs will be included in the aim focused on the Oncotype DX Breast DCIS score®. Multivariate conditional logistic regression will be used for statistical analyses. Ethics approval was obtained from the Institutional Review Boards of Albert Einstein College of Medicine (IRB 2014-3611), Kaiser Permanente Colorado, Kaiser Permanente Hawaii, Henry Ford Health System, Mayo Clinic, Marshfield Clinic Research Institute and Hackensack Meridian Health, and from Lifespan Research Protection Office. The study results will be presented at meetings and published in peer-reviewed journals.
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影响因子：
7.3
作者：
Bombonati, Alessandro;Sgroi, Dennis C.
通讯作者：
Sgroi, Dennis C.
影响因子：
2
作者：
Kooperberg, C;Aragaki, A;Olson, JM
通讯作者：
Olson, JM
影响因子：
4.8
作者：
Hafner, Markus;Renwick, Neil;Farazi, Thalia A.;Mihailovic, Aleksandra;Pena, John T. G.;Tuschl, Thomas
通讯作者：
Tuschl, Thomas
DOI：
10.4137/bcbcr.s39384
发表时间：
2016
期刊：
Breast cancer : basic and clinical research
影响因子：
--
作者：
Danforth DN Jr
通讯作者：
Danforth DN Jr
DOI：
10.1186/bcr1798
发表时间：
2007
期刊：
Breast cancer research : BCR
影响因子：
--
作者：
Dowsett M;Goldhirsch A;Hayes DF;Senn HJ;Wood W;Viale G
通讯作者：
Viale G