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NCT Number: NCT04907422

Diagnostic and Prognostic Accuracy of Gold Nanoparticles in Salivary Gland Tumours

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.

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Key information

Conditions

Carcinoma Ex Pleomorphic Adenoma of Salivary Glands Hypersensitivity Immune System Diseases Pleomorphic Adenoma of Salivary Glands

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, October 6 University

Giza, 12511, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction

Diagnostic Test

new strategy where gold nanoparticles synthetized and added to CD24 primer forming CD24-Gold Nanocomposite to be used for detection of cancer stem cells

Other names: CD24-AuNC expression using Real-time qPCR

non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction

Diagnostic Test

conventional strategy using non-conjugated CD24 expression to used for detection of cancer stem cells

Other names: CD24 expression using Real-time qPCR

Primary outcomes

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

    Time frame: 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 outcomes

  1. Clinicopathological characteristics of the patients and their association with CD24-AuNC (Index test) and non-conjugated CD24 (Reference test) expressions

    Time frame: 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

  2. Prognostic significance of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in assessing disease progression and/or patient survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Amina Fouad Farag

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
May 28, 2021
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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