Diagnostic and Prognostic Accuracy of Gold Nanoparticles in Salivary Gland Tumours

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Carcinoma Ex Pleomorphic Adenoma of Salivary Glands, Pleomorphic Adenoma of Salivary Glands

Intervention / Treatment
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* Diagnostic Test: CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction
* Diagnostic Test: non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CXPA group<br>carcinoma ex pleomorphic adenoma of major and minor salivary glands. | Diagnostic Test: CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction<br>* new strategy where gold nanoparticles synthetized and added to CD24 primer forming CD24-Gold Nanocomposite to be used for detection of cancer stem cells<br>* Other names: CD24-AuNC expression using Real-time qPCR;Diagnostic Test: non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction<br>* conventional strategy using non-conjugated CD24 expression to used for detection of cancer stem cells<br>* Other names: CD24 expression using Real-time qPCR;|
| PA group<br>Benign pleomorphic adenoma of major and minor salivary glands. | Diagnostic Test: CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction<br>* new strategy where gold nanoparticles synthetized and added to CD24 primer forming CD24-Gold Nanocomposite to be used for detection of cancer stem cells<br>* Other names: CD24-AuNC expression using Real-time qPCR;Diagnostic Test: non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction<br>* conventional strategy using non-conjugated CD24 expression to used for detection of cancer stem cells<br>* Other names: CD24 expression using Real-time qPCR;|
| Control group<br>normal controls obtained from border of excision biopsy of mucocele in the lip mucosa of healthy individuals. | Diagnostic Test: CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction<br>* new strategy where gold nanoparticles synthetized and added to CD24 primer forming CD24-Gold Nanocomposite to be used for detection of cancer stem cells<br>* Other names: CD24-AuNC expression using Real-time qPCR;Diagnostic Test: non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction<br>* conventional strategy using non-conjugated CD24 expression to used for detection of cancer stem cells<br>* Other names: CD24 expression using Real-time qPCR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic potential of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in determination of salivary gland tumours | 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, | Done immediately following completion of assessment for eligibility of enrolment in the present study (enrolment took about 6 months) and confirmation of definite diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinicopathological characteristics of the patients and their association with CD24-AuNC (Index test) and non-conjugated CD24 (Reference test) expressions | We investigated the relationship between both biomarkers' expression and clinicopathological characteristics of PA and CXPA patients such as age, gender, tumor site, tumor size (maximum diameter in mm), histopathological subtype, encapsulation, degree of invasion, facial nerve involvement and lymph node (LN) metastasis that may have direct relation with the tumor prognosis | 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 | we assessed the disease progression and/or patient survival and examined its association with biomarkers expression | At regular intervals every 3 months for 24-months (follow-up period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer stem cells, CD24-Gold Nanocomposite, CD24, Gold nanoparticles, Sensitivity, Specificity