Odontogenic CystsNCT06833840
Evaluation of the Expression and Prognostic Role of Tumor Stem Cell Marker SOX2 in Odontogenic Cysts and Tumors
An observational study of Odontogenic Cysts and Odontogenic Tumors, run by Mansoura University at 1 site in Egypt.
Trial summary
The pathogenesis of odontogenic lesions remains unclear; however, a probable explanation may involve the existence of tumor stem cells (TSCs), which are thought to generate both benign and malignant tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Odontogenic Cysts, Odontogenic Tumors
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Dec 2023
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
Who may be able to join
- 1. Patients with benign odontogenic cysts and tumors which presented either in Maxilla or Mandible ( as indicated by incisional biopsies )
Who cannot join
- Patients with systemic diseases that absolutely contraindicate surgical procedures.
- Malignant odontogenic tumors.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 12345
About this study
Official title: Evaluation of the Prognostic Role of SOX2 as a Tumor Stem Cell Marker in Odontogenic Cysts and Tumors
The pathogenesis of odontogenic lesions remains unclear; however, a probable explanation may involve the existence of tumor stem cells (TSCs), which are thought to generate both benign and malignant tumors. The preservation of stem cells during early dental development is governed by many transcription factors, including sex-determining region Y (SRY)-box 2 (SOX-2). Numerous studies observed the increased expression of SOX2 in various benign and malignant tumors, as its impact on tumorigenesis varies according to tumor type. The purpose of this study is to assess the immunoexpression of the stem cell marker SOX2 in diverse types of odontogenic cysts and tumors in order to identify its prognostic significance and to show if it correlates to clinicopathologic parameters of those odontogenic lesions.
Read the detailed description
Forty-five surgical specimens were included in this study: 15 ameloblastomas (Ab), 15 odontogenic keratocysts (OKC), and 15 dentigerous cysts (DC). An immunohistochemical (IHC) study using the SOX2 Rabbit Polyclonal Antibody was done, and SOX2 expression was evaluated by two methods: computer-assisted digital image analysis to measure staining surface area percentage and a semi-quantitative method for subjectively scoring percentage and intensity of SOX2 staining. Positive specimens were considered when the nucleus had brown staining.
- Conditions
- Odontogenic Cysts, Odontogenic Tumors
- Keywords
- Ameloblastoma, odontogenic keratocyst, dentigerous cyst, SOX2, immunohistochemistry
- Medical subject headings
- Odontogenic Cysts, Odontogenic Tumors, Ameloblastoma, Dentigerous Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ameloblastoma group | patients diagnosed with ameloblastoma | |
| Odontogenic keratocyst group | patients diagnosed with Odontogenic keratocyst | |
| Dentigerous cyst group | patients diagnosed with Dentigerous cyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOX2 staining score
Semi-quantitative method for subjectively scoring the immunohistochemical staining. Positive specimens were considered when the nucleus had brown staining.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Apr 2022
- Primary completion30 Mar 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Odontogenic CystsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833840
- Sponsor's protocol ID
- A06010222
- Status last verified
- Feb 2025
- First submitted
- 21 Jan 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeen El-Abdeen HM, Tawfik MA, Elnagdy SY, Mansour NA. Evaluation of the prognostic role of SOX2 as a tumor stem cell marker in odontogenic cysts and tumors: clinical, radiographic and immunohistochemical correlation. BMC Oral Health. 2025 Nov 1;25(1):1720. doi: 10.1186/s12903-025-07065-0.
PubMed 41176605
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Role of SOX2 as a Tumor Stem Cell Marker in Odontogenic Cysts and Tumors
- ClinicalTrials.gov ID
- NCT06833840
- Acronym / sponsor ID
- A06010222
- Conditions
- Odontogenic Cysts, Odontogenic Tumors
- Keywords
- Ameloblastoma, odontogenic keratocyst, dentigerous cyst, SOX2, immunohistochemistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 19 Feb 2025 (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.
The pathogenesis of odontogenic lesions remains unclear; however, a probable explanation may involve the existence of tumor stem cells (TSCs), which are thought to generate both benign and malignant tumors. The preservation of stem cells during early dental development is governed by many transcription factors, including sex-determining region Y (SRY)-box 2 (SOX-2). Numerous studies observed the increased expression of SOX2 in various benign and malignant tumors, as its impact on tumorigenesis varies according to tumor type. The purpose of this study is to assess the immunoexpression of the stem cell marker SOX2 in diverse types of odontogenic cysts and tumors in order to identify its prognostic significance and to show if it correlates to clinicopathologic parameters of those odontogenic lesions.
Detailed description
Forty-five surgical specimens were included in this study: 15 ameloblastomas (Ab), 15 odontogenic keratocysts (OKC), and 15 dentigerous cysts (DC). An immunohistochemical (IHC) study using the SOX2 Rabbit Polyclonal Antibody was done, and SOX2 expression was evaluated by two methods: computer-assisted digital image analysis to measure staining surface area percentage and a semi-quantitative method for subjectively scoring percentage and intensity of SOX2 staining. Positive specimens were considered when the nucleus had brown staining.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ameloblastoma group | – | –patients diagnosed with ameloblastoma |
| Odontogenic keratocyst group | – | –patients diagnosed with Odontogenic keratocyst |
| Dentigerous cyst group | – | –patients diagnosed with Dentigerous cyst |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
Key inclusion criteria (1 listed)
- 1. Patients with benign odontogenic cysts and tumors which presented either in Maxilla or Mandible ( as indicated by incisional biopsies )
Key exclusion criteria (2 listed)
- Patients with systemic diseases that absolutely contraindicate surgical procedures.
- Malignant odontogenic tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SOX2 staining score
Time frame: 6 months
Semi-quantitative method for subjectively scoring the immunohistochemical staining. Positive specimens were considered when the nucleus had brown staining.
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 26 Feb 2025.
- Derived from this study: PubMed 41176605Zeen El-Abdeen HM, Tawfik MA, Elnagdy SY, Mansour NA. Evaluation of the prognostic role of SOX2 as a tumor stem cell marker in odontogenic cysts and tumors: clinical, radiographic and immunohistochemical correlation. BMC Oral Health. 2025 Nov 1;25(1):1720. doi: 10.1186/s12903-025-07065-0.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Odontogenic Cysts and Odontogenic Tumors, run by Mansoura University 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 1 inclusion and 2 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 26 Feb 2025. 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?
SOX2 staining score (time frame: 6 months). 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 NCT06833840, which also lists 1 linked publication.
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 26 Feb 2025.