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临床试验/NCT06154551
NCT06154551已完成不适用

Evaluation of the Levels of Salivary Paxillin Oral Premalignant and Malignant Lesions

Cairo University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
salivary levels of paxillin

研究概览

简要总结

This investigation was carried out to analyze and compare the salivary paxillin levels between oral premalignant and malignant lesions (OPMLs), OSCC and the healthy controls in order to assess its potential role as a biomarker of oral cancer aiming for early diagnosis and better prognosis of OSCC.

Methods: Forty-five patients, ranging in age from thirty to seventy-five, were divided into three groups: fifteen patients with OPMLs (lichen planus, leukoplakia), fifteen patients with OSCC, and fifteen controls who were in general well. Paxillin was identified in saliva samples by using an ELISA kit.

详细描述

The aim of this study is: comparison of salivary paxillin levels in oral premalignant lesions and OSCC to its levels in healthy subjects.

Subjects and Methods Forty-five participants between the ages of 30 and 70 were accepted for this study. They were registered in the outpatient's clinic of Oral Medicine and Periodontology department in Faculty of Dentistry,Cairo university. Three sets of subjects were assigned: fifteen patients with premalignant lesions, fifteen patients with OSCC, and fifteen systemically healthy control subjects. A complete medical history was obtained for each individual using a modified Cornell Medical Index questionnaire. Upon receiving clarification regarding the scope of the inquiry, each participant completed an informed consent form.

Patients with OSCC were clinically diagnosed, and biopsy specimens from the lesions were taken for histology to confirm the diagnosis.

Collection of saliva samples:

Unstimulated Salivary samples were collected once preoperatively before any intervention All participants were asked to refrain from drinking, eating, or chewing gum for at least 60 minutes before sampling. Samples were collected by asking the patient to swallow first, then lean the head forward for 5 minutes and spit the entire saliva into 50-ml sterile centrifuge tubes. After being assembled, all specimens were immediately stored at -20 ºC until tested.

研究设计

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

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with leukoplakia patients with atropic lichen planus patients with bullous erosive lichen planus patients with squamous cell carcinoma

排除标准

  • patients with papular lichen planus patients with underlying systemic disease leukemic patients smokers hepatic patients

结局指标

主要结局

salivary levels of paxillin

时间窗: once preoperatively

to detect the levels of salivary paxillin and compare its levels in the three study groups

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

Yasmine Kamal

lecturer of oral medicine

Cairo University

研究点 (1)

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