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临床试验/NCT04907422
NCT04907422已完成不适用

Gold Nanoparticles as Novel Biomarkers for Cancer Stem Cells in Salivary Gland Tumors: A Diagnostic and Prognostic Accuracy Study

Amina Fouad Farag1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Diagnostic potential of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in determination of salivary gland tumours

研究概览

简要总结

Nano-based diagnostic tool can provide promising highly sensitive, specific biomarker for early detection and treatment of salivary gland tumours compared to non-conjugated biomarkers and in turn improves patient prognosis and outcome.

详细描述

Cancer stem cells form a small subset of highly tumorigenic cells within the bulk of the tumours which mainly responsible for initiation, invasion, rapid growth, metastasis and therapeutic resistance in different types of human cancers. Nowadays, nanotechnology has increasing attention in multi-disciplinary research fields. Conjugated gold nanoparticles are widely used as biomarkers and bio-delivery vehicles in the medicine as well as early and advanced cancer detection and treatment. The current work aimed to introduce a novel diagnostic and prognostic approach in early detection of cancer stem cells in salivary gland tumours using gold nanoparticles conjugated to CD24 (CD24-Gold Nanocomposite).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Benign PA of major and minor salivary glands (PA group),
  • CXPA of major and minor salivary glands (CXPA group).
  • Border of excision biopsy of mucocele in the lip mucosa of healthy individuals used as normal controls (Control group).
  • Surgical excision of tumors with no preoperative chemotherapy or radiotherapy. For parotid tumours partial or total parotidectomy, Surgery was performed with or without facial nerve preservation and the later was carried out commonly when the nerve was involved by tumour. For tumours in the other glands, complete surgical excision with the involved gland and the suspicious adjacent structures was performed.

排除标准

  • All epithelial origin salivary gland tumours other than PA and CXPA.
  • All mesenchymal origin salivary gland tumours.
  • All inflammatory and cystic lesions of salivary glands.
  • Metastasis in salivary glands.
  • Patients received preoperative chemotherapy or radiotherapy.

结局指标

主要结局

Diagnostic potential of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in determination of salivary gland tumours

时间窗: Done immediately following completion of assessment for eligibility of enrolment in the present study (enrolment took about 6 months) and confirmation of definite diagnosis

we tested the differential expression of CD24-AuNC and non-conjugated CD24 biomarkers in all studied groups in order to identify the most sensitive and specific diagnostic biomarker to be used in detecting salivary gland tumours,

次要结局

  • Clinicopathological characteristics of the patients and their association with CD24-AuNC (Index test) and non-conjugated CD24 (Reference test) expressions(Done immediately following completion of assessment for eligibility of enrolment in the present study (enrolment took about 6 months) and confirmation of definite diagnosis)
  • Prognostic significance of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in assessing disease progression and/or patient survival(At regular intervals every 3 months for 24-months (follow-up period))

研究者

发起方
Amina Fouad Farag
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amina Fouad Farag

Lecturer of Oral and Maxillofacial Pathology, Oral Pathology Department, Faculty of Dentistry

October 6 University

研究点 (1)

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