- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06833840
Evaluation of the Expression and Prognostic Role of Tumor Stem Cell Marker SOX2 in Odontogenic Cysts and Tumors
February 24, 2025 updated by: Mansoura University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Dakahlia
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Mansoura, Dakahlia, Egypt, 12345
- Faculty of Dentistry, Mansoura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients in the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
Description
Inclusion criteria:
1. Patients with benign odontogenic cysts and tumors which presented either in Maxilla or Mandible ( as indicated by incisional biopsies )
Exclusion criteria:
- Patients with systemic diseases that absolutely contraindicate surgical procedures.
- Malignant odontogenic tumors.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Ameloblastoma group
patients diagnosed with ameloblastoma
|
|
Odontogenic keratocyst group
patients diagnosed with Odontogenic keratocyst
|
|
Dentigerous cyst group
patients diagnosed with Dentigerous cyst
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
January 21, 2025
First Submitted That Met QC Criteria
February 13, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 24, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A06010222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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