Diagnostic and Prognostic Accuracy of Gold Nanoparticles in Salivary Gland Tumours

NCT ID: NCT04907422

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-06

Study Completion Date

2021-02-03

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).

Conditions

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Carcinoma Ex Pleomorphic Adenoma of Salivary Glands Pleomorphic Adenoma of Salivary Glands

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CXPA group

carcinoma ex pleomorphic adenoma of major and minor salivary glands.

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

Intervention Type 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

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

Intervention Type DIAGNOSTIC_TEST

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

PA group

Benign pleomorphic adenoma of major and minor salivary glands.

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

Intervention Type 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

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

Intervention Type DIAGNOSTIC_TEST

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

Control group

normal controls obtained from border of excision biopsy of mucocele in the lip mucosa of healthy individuals.

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

Intervention Type 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

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CD24-AuNC expression using Real-time qPCR CD24 expression using Real-time qPCR

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amina Fouad Farag

OTHER

Sponsor Role lead

Responsible Party

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Amina Fouad Farag

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

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Amina F Farag, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, October 6 University

Locations

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Faculty of Dentistry, October 6 University

Giza, , Egypt

Site Status

Countries

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Egypt

References

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Kesharwani P, Ma R, Sang L, Fatima M, Sheikh A, Abourehab MAS, Gupta N, Chen ZS, Zhou Y. Gold nanoparticles and gold nanorods in the landscape of cancer therapy. Mol Cancer. 2023 Jun 21;22(1):98. doi: 10.1186/s12943-023-01798-8.

Reference Type DERIVED
PMID: 37344887 (View on PubMed)

Farag AF, Hassabou NF. CD24-gold nanocomposite as promising and sensitive biomarker for cancer stem cells in salivary gland tumors. Nanomedicine. 2022 Nov;46:102598. doi: 10.1016/j.nano.2022.102598. Epub 2022 Sep 8.

Reference Type DERIVED
PMID: 36089234 (View on PubMed)

Other Identifiers

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RECO6U/5-2018

Identifier Type: -

Identifier Source: org_study_id

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