- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04759261
SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
Non-melanocytic skin cancers are the most common type of cancer worldwide. In the development of this cancer type, environmental factors such as UV and smoking are emphasized.
Epigenetics are genetic conditions that develop due to environmental factors and can be inherited. Epigenetic modifications such as DNA methylation play an integral role in carcinogenesis, cancer progression and metastasis.
The TGF-/ SMAD4 pathway plays a tumor suppressive role in cancer pathogenesis. Epigenetic changes in this pathway also lead to a decrease in expression level, leading to different types of cancer. However, there is no study showing the epigenetic relationship between non-melanocytic skin cancer and SMAD4 methylation.
In this study we planned, it was aimed to show the change in SMAD4 methylation and SMAD4 RNA expression level in cancerous tissue. In addition, it is planned to measure the SMAD4 protein positivity rate in non-melanocytic cancers as an immunohistochemical marker.
In this context, 60 patients who applied to Trakya University Dermatology and Venereal Diseases Outpatient Clinic and diagnosed with non-melanocytic skin cancer clinically and dermoscopically will be included in the study. Tissue materials obtained from both cancerous and intact skin of the patients will be examined in Trakya University Medical Biophysics and Medicine Pathology laboratories through various steps.
Our project is the first study to be conducted on this subject in terms of handling all non-melanocytic skin cancers, using human tissue and having a large sample.
In addition, with the data to be obtained; We think that better clarification of the role of SMAD4 in non-melanocytic cancers and the use of SMAD4 as both a prognostic factor and an immunohistochemical marker in future studies will prevent this study.
Again, we anticipate that different treatment modalities will be developed and different functional studies can be designed through this pathway.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yildiz Gursel, MD
- Phone Number: 90 505 537 30 63
- Email: yildizgrsl@gmail.com
Study Locations
-
-
-
Edirne, Turkey, 22000
- Recruiting
- Trakya University
-
Contact:
- Yildiz Gursel, MD
- Phone Number: +905055373063
- Email: ygurselu@gmail.com
-
Principal Investigator:
- Metin Budak, PhD
-
Principal Investigator:
- Fatma El Ustrali Keskin, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- People diagnosed clinically and dermoscopically with non-melanocytic skin cancer
- No other cancer history
- over 18 years old
- Newly diagnosed
- No systemic or topical therapy
Exclusion Criteria:
- Under 18 and pregnant
- People with non-melanocytic skin cancer who are in the process of follow-up and treatment
- has another cancer history
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Study group
|
Effect of SMAD4 methylations on smad4 expression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of SMAD4 methylations and expression
Time Frame: 2 years
|
Detection of SMAD4 methylations on tumor tissues
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Metin Budak, Trakya University
- Principal Investigator: Fatma El Usturali Keskin, MD, Trakya University
- Study Director: Yildiz Gursel, MD, Trakya University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/55
- SMAD4 (Other Identifier: Trakya University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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