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临床试验/NCT06529588
NCT06529588已完成不适用

Soluble Urokinase Plasminogen Activator Receptor (suPAR) is a Potential Biomarker of Stage III-IV, Grade C Periodontitis Through the Impact of Post-radiotherapy on Head and Neck Cancer Patients

Al-Maarif University College1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年9月1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
150
试验地点
1
主要终点
Measure of serum suPAR level

研究概览

简要总结

This study aims to improve a soluble urokinase plasminogen activator receptor suPAR is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (HNC post-RT).

详细描述

The urokinase-type plasminogen activator receptor (uPAR) plays an essential function in leukocytes and endothelial homeostasis and, therefore, in the development of chronic periodontitis. The study enrolled 150 participants, 50 chronic periodontitis with head and neck cancer post radiotherapy (CP+HNC post-RT) patients, 50 chronic periodontitis (CP) without HNC patients, and 50 healthy controls. Clinical Attachment Loss (CAL), Probing Pocket Depth (PPD), Plaque Index (PI), and Gingival Bleeding Index (GBI) were recorded. An enzyme-linked immunosorbent assay (ELISA) was constructed to quantify serum (suPAR) levels.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
28 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A pathologically confirmed malignant neoplasm of HNC (derived from epithelial cells).
  • Not having received radiation therapy previously.
  • No distant metastasis.
  • No history of salivary gland surgery (parotid, submandibular, or sublingual).
  • A generally satisfactory physical condition with a performance score of 0 to 1 point and a planned survival period of more than a year and scores of 2 higher indicating increasing disability.

排除标准

  • Previous oral disease or salivary gland disease history.
  • Definitive diagnosis of multiple sclerosis, xerostomia, or systemic disease.
  • Refusal to participate in the study.

结局指标

主要结局

Measure of serum suPAR level

时间窗: 6 months

Measure of serum suPAR level in patients head and neck cancer who received radiotherapy

Clinical Periodontal parameters measured

时间窗: 6 months

Periodontal parameters included (CAL, PI, GBI, PPD) measured by using a millimeter periodontal probe in patients with head and neck cancer who received radiotherapy.

次要结局

  • Oral pH-saliva was measured(6 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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