上海口腔医学

上海口腔医学 ›› 2021, Vol. 30 ›› Issue (5): 511-516.doi: 10.19439/j.sjos.2021.05.012

• 论著 • 上一篇    下一篇

基于WHO-ICTRP注册平台分析的黏膜黑色素瘤临床研究注册特点分析

石超吉, 黄铖, 陈茹, 周榕, 韩永, 徐声铭, 李楚文, 陆海霞*, 张志愿*   

  1. 上海交通大学医学院附属第九人民医院,上海交通大学口腔医学院,国家口腔医学中心,国家口腔疾病临床医学研究中心,上海市口腔医学重点实验室,上海 200011
  • 收稿日期:2020-03-31 修回日期:2020-06-23 出版日期:2021-10-25 发布日期:2021-11-08
  • 通讯作者: 张志愿,E-mail：zhzhy0502@163.com;陆海霞,E-mail：ritalu0225@hotmail.com。*共同通信作者
  • 作者简介:石超吉（1988-）,男,博士研究生,E-mail:scjtdcq@126.com
  • 基金资助:
    上海市重中之重临床医学中心（2017ZZ01011）; 上海市临床重点专科建设项目（shslczdzk01601）; 上海市口腔疾病临床医学研究中心科研资助项目（19MC1910600）

Characteristics of clinical trials of mucosal melanoma registered in WHO ICTRP

SHI Chao-ji, HUANG Cheng, CHEN Ru, ZHOU Rong, HAN Yong, XU Sheng-ming, LI Chu-wen, LU Hai-xia, ZHANG Zhi-yuan   

  1. Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; College of Stomatology, Shanghai Jiao Tong University; National Center for Stomatology; National Clinical Research Center for Oral Diseases; Shanghai Key Laboratory of Stomatology. Shanghai 200011, China
  • Received:2020-03-31 Revised:2020-06-23 Online:2021-10-25 Published:2021-11-08

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摘要： 目的: 基于WHO 国际临床试验注册平台（ICTRP）,研究黏膜黑色素瘤临床研究注册特点,为黏膜黑色素瘤的临床转化研究提供参考。方法: 检索WHO ICTRP临床试验注册平台数据,由2名研究者独立筛选注册项目、提取资料,对纳入的临床研究项目从注册数量、研究阶段、国家/地区、临床研究设计等方面进行描述性分析。结果: 51项涉及黏膜黑色素瘤的临床研究项目纳入本研究。项目开展国家与地区主要分布在欧美国家与东亚地区,头颈黏膜黑色素瘤临床研究主要在东亚地区开展（11/12）。研究者发起的项目48项,生物医药公司发起的项目3项。研究实施单位以单中心为主（42项）,多为Ⅱ期临床试验（38项）。临床试验的干预措施复杂多样,药物治疗和多种方式联合治疗占据主导地位。结论: 通过对WHO ICTRP上注册的有关黏膜黑色素瘤临床研究的特点进行统计和分析,发现黏膜黑色素瘤临床研究数量偏少,受关注度不高。黏膜黑色素瘤临床研究的水平有待提高。

关键词: 黏膜黑色素瘤, 临床试验, WHO国际临床试验注册平台, 注册特点

Abstract: PURPOSE: To analyze the characteristics of clinical trials of mucosal melanoma (MM) based on WHO international clinical trial registration platform (ICTRP), in order to provide a reference for clinical translational research of mucosal melanoma. METHODS: WHO ICTRP database were searched to collect MM-related clinical trials. Two reviewers independently screened items, extracted data, and descriptive analysis was performed for the included trials, including number of registrations, research phase, country/region, clinical study design, etc. RESULTS: The results showed that there were 51 registered clinical trials involving MM. European and American countries and East Asia were the main study sites, and head and neck MM were mainly investigated in East Asia (11/12). Forty-eight of them were sponsored by investigators, and only 3 were sponsored by biomedical companies. The main clinical trials were single center (42 items) and in stage II (38 items). Interventions were complex, and multiple treatments and drug therapy accounted a dominant position. CONCLUSIONS: In-depth analysis of clinical trials information can help to understand the current situation and development trends in the field of mucosal melanoma. The number of clinical studies of mucosal melanoma is relatively small and has not received much attention.

Key words: Mucosal Melanoma, Clinical trials, WHO ICTRP, Registration characteristics

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