跳至主要内容
临床试验/NCT03075098
NCT03075098Unknown不适用

Diagnostic Accuracy Of Colposcopic Examination in Patients With Oral Dysplastic Lesion (Diagnostic Accuracy Study)

Cairo University0 个研究点目标入组 25 人开始时间: 2017年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
主要终点
Diagnostic accuracy of colposcopic examination

研究概览

简要总结

The aim of this work is to detect the diagnostic accuracy of the intra-oral application of colposcope in diagnosing oral dysplastic lesions in comparison to biopsy taking and histopathological examination.

详细描述

A- Roles and Responsibilities:

  1. The Principle Supervisor: Dr. Mohsen Kazem (M.K.), Professor of Oral &Maxillofacial Pathology, Cairo University, will examine the taken biopsy histopathologically and determine the definitive diagnosis.
  2. The Assistant Supervisor: Dr. Heba Dahmoush (H.D.), Professor of Oral & Maxillofacial Pathology, Cairo University, will examine the taken biopsy histopathologically and determine the definitive diagnosis.
  3. The Principle Investigator: Sarah Ahmed Mohamed Mahmoud Badawy (S.B.), Assistant Lecturer of Oral &Maxillofacial Pathology, Cairo University, will read and put a colposcopic score for each participant individually.
  4. Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  5. Evidence Based Committee, Faculty of Dentistry, Cairo University: Help in reporting study protocol following STARD guidelines.
  6. Ethics Committee, Faculty of Dentistry, Cairo University: Protocol reviewer of the diagnostic accuracy study in order to protect the right, safety, dignity and well-being of the participants.

B- Index test: The principle investigator (S.B.) will perform the index test using Digital Electronic Colposcope (Kernel, KN-2200, China). Before taking up the patients for Colposcopic evaluation and giving them a score, the normal Colposcopic findings will be standardized based on the Colposcopic criteria. Colposcopic criteria includes aceto uptake, surface pattern and clarity of demarcation of the mucosal lesions, vascular pattern, lesion size as well as Iodine staining.

C- Reference test:The reference standard; to reach a definitive diagnosis in oral dysplastic lesions, will be a representative biopsy and histopathological examination. M.K. and H.D. will examine the taken biopsy histopathologically, determine the definitive diagnosis and write the diagnosis in the Assessor chart.

Inclusion criteria:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients seeking for diagnosis of clinically suspected oral dysplastic Leukoplakia or Erythroplakia
  • Patients seeking for diagnosis of clinically suspected oral Carcinoma.

排除标准

  • Patients with secondary infection.
  • Patients having other systemic diseases.
  • Patients undergoing treatment for the lesions.

结局指标

主要结局

Diagnostic accuracy of colposcopic examination

时间窗: Baseline

using digital colposcope (Kernel, KN-2200, China)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah badway

assistant lecturer, oral & maxillofacial pathology department, cairo university

Cairo University

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