跳至主要内容
临床试验/NCT04547673
NCT04547673招募中不适用

To Develop and Validate a Nasoendoscopic Intelligent Diagnostic System for Nasopharyngeal Carcinoma

First Affiliated Hospital, Sun Yat-Sen University3 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
3
主要终点
Pathological diagnosis

研究概览

简要总结

Nasopharyngeal carcinoma (NPC) occurs at a high frequency in southern China, northern Africa, and Alaska, with a reported incidence of 30 cases per 100 000 in Guangdong Province. Endoscopic examination and biopsy are the main methods used for detection and diagnosis of NPC. Early NPC patients achieve favourable prognoses after concurrent radiotherapy and chemotherapy in compassion with advanced NPC patients.

Here, the investigators focused on the utility of artificial intelligence to detect early NPC, which based on white light imaging (WLI) and Narrow-band imaging (NBI) nasoendoscopic examination. Having access to this unique population provides an unprecedented opportunity to investigate the effect of intelligent system on diverse nasopharyngeal lesions detection and develop a novel Computer-Aided Diagnosis System.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years of age

排除标准

  • Refuse to sign the informed consent statement
  • Patients who have contraindications, e.g. coagulation dysfunction, drug allergy.

结局指标

主要结局

Pathological diagnosis

时间窗: baseline

All lesions, detected by either WLI or NBI, are biopsied. 2 experienced pathologists, who were blinded to the endoscopic and intelligent assessment, evaluate the pathological nature of the biopsied lesion independently, and 2 professors with over 10 years of experience in Otolaryngology and pathology department are consulted in cases of disagreement.

次要结局

  • Lesion range(baseline)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weiping Wen

Vice President of First Affiliated Hospital, Sun Yat-Sen University; President of sixth Affiliated Hospital, Sun Yat-Sen University

First Affiliated Hospital, Sun Yat-Sen University

研究点 (3)

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