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Diagnostic and Prognostic Accuracy of Gold Nanoparticles in Salivary Gland Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04907422
Recruitment Status : Completed
First Posted : May 28, 2021
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Amina Fouad Farag, October 6 University

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.

Condition or disease Intervention/treatment
Carcinoma Ex Pleomorphic Adenoma of Salivary Glands Pleomorphic Adenoma of Salivary Glands 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

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).

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gold Nanoparticles as Novel Biomarkers for Cancer Stem Cells in Salivary Gland Tumors: A Diagnostic and Prognostic Accuracy Study
Actual Study Start Date : August 6, 2018
Actual Primary Completion Date : February 3, 2019
Actual Study Completion Date : February 3, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CXPA group
carcinoma ex pleomorphic adenoma of major and minor salivary glands.
Diagnostic Test: 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
Other Name: CD24-AuNC expression using Real-time qPCR

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
Other Name: CD24 expression using Real-time qPCR

PA group
Benign pleomorphic adenoma of major and minor salivary glands.
Diagnostic Test: 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
Other Name: CD24-AuNC expression using Real-time qPCR

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
Other Name: CD24 expression using Real-time qPCR

Control group
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
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 Name: CD24-AuNC expression using Real-time qPCR

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
Other Name: CD24 expression using Real-time qPCR




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Briefly, a portion of surgically resected salivary gland tumour specimens was immersed immediately in liquid nitrogen, allowed to snap frozen and stored at -80 C (Frozen tissue) while the other portion was fixed in 10% buffered formalin solution and embedded in paraffin (Formalin-fixed paraffin-embedded tissue)


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04907422


Locations
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Egypt
Faculty of Dentistry, October 6 University
Giza, Egypt, 12511
Sponsors and Collaborators
Amina Fouad Farag
Investigators
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Principal Investigator: Amina F Farag, PhD Faculty of Dentistry, October 6 University
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Responsible Party: Amina Fouad Farag, Lecturer of Oral and Maxillofacial Pathology, Oral Pathology Department, Faculty of Dentistry, October 6 University
ClinicalTrials.gov Identifier: NCT04907422    
Other Study ID Numbers: RECO6U/5-2018
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amina Fouad Farag, October 6 University:
Cancer stem cells
CD24-Gold Nanocomposite
CD24
Gold nanoparticles
Sensitivity
Specificity
Additional relevant MeSH terms:
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Adenoma
Salivary Gland Neoplasms
Adenoma, Pleomorphic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Neoplasms, Complex and Mixed