Diagnostic and Prognostic Accuracy of Gold Nanoparticles in Salivary Gland Tumours

Completed

• Conditions: Carcinoma Ex Pleomorphic Adenoma of Salivary Glands; Pleomorphic Adenoma of Salivary Glands
• Interventions: 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

• Registration Number: NCT04907422
• Lead Sponsor: Amina Fouad Farag

Brief Summary

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

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).

Study Timeline

• Study Start: 2018-08-06
• Primary Completion: 2019-02-03
• Study Completion: 2021-02-03
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-05-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction	normal controls obtained from border of excision biopsy of mucocele in the lip mucosa of healthy individuals.
PA group	non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction	Benign pleomorphic adenoma of major and minor salivary glands.
CXPA group	CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction	carcinoma ex pleomorphic adenoma of major and minor salivary glands.
CXPA group	non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction	carcinoma ex pleomorphic adenoma of major and minor salivary glands.
PA group	CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction	Benign pleomorphic adenoma of major and minor salivary glands.
Control group	CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction	normal controls obtained from border of excision biopsy of mucocele in the lip mucosa of healthy individuals.

Primary Outcome Measures

Name	Time	Method
Diagnostic potential of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in determination of 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	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,

Secondary Outcome Measures

Name	Time	Method
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	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
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)	we assessed the disease progression and/or patient survival and examined its association with biomarkers expression

Trial Locations

Locations (1)

Faculty of Dentistry, October 6 University; 🇪🇬 Giza, Egypt