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宫颈癌研究网络:增加低收入和中等收入国家癌症临床试验的可及性

The cervix cancer research network: increasing access to cancer clinical trials in low- and middle-income countries.

作者信息

Suneja Gita, Bacon Monica, Small William, Ryu Sang Y, Kitchener Henry C, Gaffney David K

机构信息

Department of Radiation Oncology, University of Utah School of Medicine , Salt Lake City, UT , USA.

GCIG: Gynecologic Cancer Intergroup , Kingston, ON , Canada.

出版信息

Front Oncol. 2015 Feb 19;5:14. doi: 10.3389/fonc.2015.00014. eCollection 2015.

Abstract

INTRODUCTION

The burden of cervical cancer is large and growing in developing countries, due in large part to limited access to screening services and lack of human papillomavirus (HPV) vaccination. In spite of modern advances in diagnostic and therapeutic modalities, outcomes from cervical cancer have not markedly improved in recent years. Novel clinical trials are urgently needed to improve outcomes from cervical cancer worldwide.

METHODS

The Cervix Cancer Research Network (CCRN), a subsidiary of the Gynecologic Cancer InterGroup, is a multi-national, multi-institutional consortium of physicians and scientists focused on improving cervical cancer outcomes worldwide by making cancer clinical trials available in low-, middle-, and high-income countries. Standard operating procedures for participation in CCRN include a pre-qualifying questionnaire to evaluate clinical activities and research infrastructure, followed by a site visit. Once a site is approved, they may choose to participate in one of four currently accruing clinical trials.

RESULTS

To date, 13 different CCRN site visits have been performed. Of these 13 sites visited, 10 have been approved as CCRN sites including Tata Memorial Hospital, India; Bangalore, India; Trivandrum, India; Ramathibodi, Thailand; Siriaj, Thailand; Pramongkutklao, Thailand; Ho Chi Minh, Vietnam; Blokhin Russian Cancer Research Center; the Hertzen Moscow Cancer Research Institute; and the Russian Scientific Center of Roentgenoradiology. The four currently accruing clinical trials are TACO, OUTBACK, INTERLACE, and SHAPE.

DISCUSSION

The CCRN has successfully enrolled eight sites in developing countries to participate in four randomized clinical trials. The primary objectives are to provide novel therapeutics to regions with the greatest need and to improve the validity and generalizability of clinical trial results by enrolling a diverse sample of patients.

摘要

引言

在发展中国家,宫颈癌负担巨大且呈增长趋势,这在很大程度上是由于筛查服务获取有限以及人乳头瘤病毒(HPV)疫苗接种缺乏。尽管诊断和治疗方式有现代进展,但近年来宫颈癌的治疗结果并未显著改善。迫切需要新的临床试验来改善全球宫颈癌的治疗结果。

方法

宫颈癌研究网络(CCRN)是妇科肿瘤协作组的一个分支机构,是一个由医生和科学家组成的跨国、多机构联盟,致力于通过在低收入、中等收入和高收入国家开展癌症临床试验来改善全球宫颈癌的治疗结果。参与CCRN的标准操作程序包括一份资格预审问卷,以评估临床活动和研究基础设施,随后进行实地考察。一旦一个站点获得批准,他们可以选择参与目前正在进行的四项临床试验之一。

结果

迄今为止,已进行了13次不同的CCRN实地考察。在这些考察的13个站点中,有10个已被批准为CCRN站点,包括印度的塔塔纪念医院;印度班加罗尔;印度特里凡得琅;泰国拉玛蒂博迪医院;泰国诗里拉吉医院;泰国挽赐皇家医院;越南胡志明市;俄罗斯布罗欣癌症研究中心;莫斯科赫岑癌症研究所;以及俄罗斯伦琴放射学科学中心。目前正在进行的四项临床试验是TACO、OUTBACK、INTERLACE和SHAPE。

讨论

CCRN已成功招募了八个发展中国家的站点参与四项随机临床试验。主要目标是为最需要的地区提供新的治疗方法,并通过招募不同样本的患者来提高临床试验结果的有效性和普遍性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cda6/4333873/d2f27134b57f/fonc-05-00014-g001.jpg

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