Clinical trial NCT04907422: Diagnostic and Prognostic Accuracy of Gold Nanoparticles in Salivary Gland Tumours
Official title: Gold Nanoparticles as Novel Biomarkers for Cancer Stem Cells in Salivary Gland Tumors: A Diagnostic and Prognostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma Ex Pleomorphic Adenoma of Salivary Glands
Pleomorphic Adenoma of Salivary Glands
Keywords: Cancer stem cells
CD24-Gold Nanocomposite
CD24
Gold nanoparticles
Sensitivity
Specificity
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presented to Oral and Maxillofacial Surgery Department, Faculty of Dentistry and Output Clinics of General Surgery Department, Faculty of Medicine, October 6 University, Giza, Egypt.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic potential of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in determination of salivary gland tumours
timeFrame: 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 outcomes:
measure: Clinicopathological characteristics of the patients and their association with CD24-AuNC (Index test) and non-conjugated CD24 (Reference test) expressions
timeFrame: Done immediately following completion of assessment for eligibility of enrolment in the present study (enrolment took about 6 months) and confirmation of definite diagnosis
measure: Prognostic significance of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in assessing disease progression and/or patient survival
timeFrame: At regular intervals every 3 months for 24-months (follow-up period)
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry, October 6 University
Study officials:
affiliation: Faculty of Dentistry, October 6 University
name: Amina F Farag, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.