Carcinoma Ex Pleomorphic Adenoma of Salivary GlandsNCT04907422
Diagnostic and Prognostic Accuracy of Gold Nanoparticles in Salivary Gland Tumours
An observational study of Carcinoma Ex Pleomorphic Adenoma of Salivary Glands and Pleomorphic Adenoma of Salivary Glands, run by Amina Fouad Farag at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carcinoma Ex Pleomorphic Adenoma of Salivary Glands, Pleomorphic Adenoma of Salivary Glands
- What is being tested?
- CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction and non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Aug 2018to 3 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gold Nanoparticles as Novel Biomarkers for Cancer Stem Cells in Salivary Gland Tumors: A Diagnostic and Prognostic Accuracy Study
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.
Read the 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).
- Conditions
- Carcinoma Ex Pleomorphic Adenoma of Salivary Glands, Pleomorphic Adenoma of Salivary Glands
- Being tested
- CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction, non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction
- Keywords
- Cancer stem cells, CD24-Gold Nanocomposite, CD24, Gold nanoparticles, Sensitivity, Specificity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reactionDiagnostic test
Also called CD24-AuNC expression using Real-time qPCR
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 reactionDiagnostic test
Also called CD24 expression using Real-time qPCR
conventional strategy using non-conjugated CD24 expression to used for detection of cancer stem cells
| Study group | Role | What they receive |
|---|---|---|
| CXPA group | carcinoma ex pleomorphic adenoma of major and minor salivary glands. Receives: 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 | |
| PA group | Benign pleomorphic adenoma of major and minor salivary glands. Receives: 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 | |
| Control group | normal controls obtained from border of excision biopsy of mucocele in the lip mucosa of healthy individuals. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic potential of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in determination of salivary gland tumours
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,
Measured: 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 (2)
Clinicopathological characteristics of the patients and their association with CD24-AuNC (Index test) and non-conjugated CD24 (Reference test) expressions
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
Measured: Done immediately following completion of assessment for eligibility of enrolment in the present study (enrolment took about 6 months) and confirmation of definite diagnosis
Prognostic significance of CD24-AuNC (index test) compared to non-conjugated CD24 (reference test) in assessing disease progression and/or patient survival
we assessed the disease progression and/or patient survival and examined its association with biomarkers expression
Measured: At regular intervals every 3 months for 24-months (follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start6 Aug 2018
- Primary completion3 Feb 2019
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma Ex Pleomorphic Adenoma of Salivary GlandsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amina Fouad Farag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amina Fouad Farag, October 6 University
- Investigators
- Amina F Farag, PhD, Principal investigator, Faculty of Dentistry, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907422
- Sponsor's protocol ID
- RECO6U/5-2018
- Status last verified
- Aug 2021
- First submitted
- 25 May 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37344887Farag 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.
PubMed 36089234
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gold Nanoparticles as Novel Biomarkers for Cancer Stem Cells in Salivary Gland Tumors: A Diagnostic and Prognostic Accuracy Study
- ClinicalTrials.gov ID
- NCT04907422
- Acronym / sponsor ID
- RECO6U/5-2018
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Amina Fouad FaragUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 3 Feb 2019 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CXPA group | – | 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 reactioncarcinoma ex pleomorphic adenoma of major and minor salivary glands. |
| PA group | – | 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 reactionBenign pleomorphic adenoma of major and minor salivary glands. |
| Control group | – | 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 reactionnormal controls obtained from border of excision biopsy of mucocele in the lip mucosa of healthy individuals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reactionAlso: CD24-AuNC expression using Real-time qPCRnew strategy where gold nanoparticles synthetized and added to CD24 primer forming CD24-Gold Nanocomposite to be used for detection of cancer stem cells | Diagnostic test | CXPA group, Control group, PA group |
| non-conjugated CD24 expression using Real-time quantitative polymerase chain reactionAlso: CD24 expression using Real-time qPCRconventional strategy using non-conjugated CD24 expression to used for detection of cancer stem cells | Diagnostic test | CXPA group, Control group, PA group |
Primary outcome
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,
2 secondary outcomes
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 37344887Kesharwani 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.
- Derived from this study: PubMed 36089234Farag 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amina F Farag, PhD principal investigator
Faculty of Dentistry, October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma Ex Pleomorphic Adenoma of Salivary Glands and Pleomorphic Adenoma of Salivary Glands, run by Amina Fouad Farag at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04907422, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.