Clinical Trial Cytology: Use of On-Site Evaluation of Small Biopsy and FNA Samples for Clinical Trials and Biomarker Research Studies
Clinical Trial Cytology: Use of On-Site Evaluation of Small Biopsy and FNA Samples for Clinical Trials and Biomarker Research Studies
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DOI：
10.1002/cncy.22001
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发表时间：
2018-07-01
影响因子：
3.4
通讯作者：
Monaco, Sara E.
中科院分区：
文献类型：
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作者：
Manzo, Julia L.;Cuda, Jackie;Monaco, Sara E.
在临床试验和生物标志物研究的活检要求增加后，匹兹堡大学医学中心创建了一个临床试验研究服务，与病理学，放射学，和药物，以促进细针抽吸（FNA）和/或粗针活检（CNB）的快速现场评价（ROSE）方法临床试验协调员为需要试验用肿瘤样本的患者组织活检，并通知了细胞病理学和放射学小组进行ROSE以确认在CNB的FNA标本和/或触摸制备物中存在足够的肿瘤。使用ROSE对来自总共14项临床试验的79例病例进行了评估，其中77例（97%）仅用于研究。有53例（67%）来自2008年至2009年期间开始的乳腺癌/卵巢癌研究，而26例（33%）包括2011年至2014年期间开始的各种其他肿瘤研究。大多数需要CNB样本（60例; 76%），其中20%在获得CNB材料之前使用FNA进行针放置，其中56%在未进行FNA的情况下评价了CNB的触摸准备。ROSE与最终样本充分性的一致率为96%~100%.CONCLUSIONS研究机构经历了要求ROSE确认各种恶性肿瘤中肿瘤存在的临床试验研究数量的增加。细胞学实验室可以通过提供ROSE来确定临床试验材料的充分性，以最大限度地减少提交不满意或不具代表性的材料，从而帮助患者护理。开发临床研究服务可以加强沟通，并为癌症患者处理新的研究标本。Cancer Cytopathol 2018; 126：481 - 89. (c)2018年美国癌症协会。由于临床试验和研究对活检的需求增加，作者的机构已经创建了一个临床试验研究服务，与病理学，放射学和医学合作，以促进对细针抽吸和/或芯针活检样本的快速现场评估，以确认这些研究中肿瘤的存在。细胞学实验室可以通过提供快速的现场评估来帮助癌症患者的护理，以确定临床试验材料的充分性，从而最大限度地减少提交不满意或不具代表性的材料。
BACKGROUNDAfter increased requests for biopsies for clinical trials and biomarker research, the University of Pittsburgh Medical Center created a clinical trial research service that partnered pathology, radiology, and medicine to facilitate rapid on-site evaluation (ROSE) of fine-needle aspiration (FNA) and/or core needle biopsy (CNB) samples to confirm the presence of tumor in these studies.METHODSClinical trial coordinators organized biopsies for patients needing tumor samples for trials, and informed the cytopathology and radiology team. ROSE was performed to confirm the presence of sufficient tumor in FNA specimens and/or touch preparations of CNB.RESULTSA total of 79 cases from a total of 14 clinical trials were evaluated with ROSE, 77 of which (97%) were for research only. There were 53 cases (67%) from breast/ovarian cancer studies that were initiated between 2008 and 2009, whereas 26 cases (33%) included a variety of other tumors for studies that were started between 2011 and 2014. The majority required CNB samples (60 cases; 76%), 20% of which used an FNA for needle placement before obtaining CNB material and 56% of which had touch preparations of the CNB evaluated without a preceding FNA. The concordance rate for ROSE with final adequacy of the sample was 96% to 100%.CONCLUSIONSThe study institution has experienced an increase in the number of clinical trial studies requesting ROSE to confirm the presence of tumor in a variety of malignancies. Cytology laboratories can help with patient care by offering ROSE to determine the adequacy of clinical trial material to minimize the submission of unsatisfactory or nonrepresentative material. Developing a clinical research service enhances communication and the processing of novel research specimens for cancer patients. Cancer Cytopathol 2018;126:481-89. (c) 2018 American Cancer Society.Due to increased requests for biopsies for clinical trials and research, the authors' institution has created a clinical trial research service, partnering pathology, radiology, and medicine to facilitate rapid on-site evaluation of fine-needle aspiration and/or core needle biopsy samples to confirm the presence of tumor in these studies. Cytology laboratories can help with the care of patients with cancer by offering rapid on-site evaluation to determine the adequacy of clinical trial material to minimize the submission of unsatisfactory or nonrepresentative material.