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临床试验/NCT06471270
NCT06471270已完成不适用

Validation of Salivary Proteomic Biomarkers for Early Detection of Oral Cancer in Egyptian Population

British University In Egypt2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月15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
100
试验地点
2
主要终点
Quantities of IL-6 and IL-8

研究概览

简要总结

The present investigation was conducted on 100 individuals allocated into four groups; 25 healthy controls, 25 patients having OPMDs with dysplasia; 25 patients having OPMDs without dysplasia, and 25 oral cancer patients. Demographic data including data related to different risk factors, modified gingival index, oral hygiene level, in addition to salivary levels of IL-6, IL-8 and sCD44 were assessed.

详细描述

Histopathologic evaluation:

Biopsy samples were obtained from all lesions to verify the diagnosis and establish the presence of dysplasia in the potentially premalignant lesions before allocating patients to their specific groups.

History and clinical assessment:

Demographic data as age and gender, medical history and habits as smoking and alcohol were obtained during patient interview. Modified gingival index (MGI), level of oral hygiene (OH) and the number of remaining natural teeth were also assessed. Subjects not willing to sign a written informed consent, pregnant females, lactating mothers, and patients with immunosuppressive disorders were excluded.

Modified gingival index (MGI) evaluates the presence and degree of gingival inflammation. A score of 0 means absence of inflammation. 1 indicates mild inflammation (slight redness) of any part of the gingiva. 2- mild inflammation of the whole gingiva. 3- moderate inflammation (moderate redness, edema, and/or hypertrophy) of the gingiva. 4-severe inflammation (marked redness and spontaneous bleeding) of the gingiva. Level of OH care was evaluated corresponding to the OH habits of the patient and efficiency of plaque removal. OH, level is scored as: 1- very good, 2- good, 3- fair, and 4- poor OH.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • patients above 18 years both males and females patients presenting with OPMDs

排除标准

  • 未提供

结局指标

主要结局

Quantities of IL-6 and IL-8

时间窗: baseline

assessed in all samples using an ELISA kit (Orgenium laboratories, Business Unit, Finland). The test principles apply a sandwich-type ELISA where a polyclonal anti-antibody, adsorbed onto microwells, binds IL-6 and IL-8 in the samples, Results were expressed in pg/ml

Levels of sCD44

时间窗: Baselone

measured using an ELISA assay (Bender MedSystems, Vienna, Austria) that identifies all normal and variant isoforms. Saliva samples were centrifuged at 2000 Xg and the supernatants were separated and stored at -80 ̊C till processing, which was done according to manufacturer's instructions. Results were expressed in ng/ml.

次要结局

  • MGI (modified gingival index)(baseline)

研究者

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

Dalia Ghalwash

PROFESSOR

British University In Egypt

研究点 (2)

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