SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04759261|
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Other: SMAD4 expression and methylation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Differantiation of tumor tissues than normal tissues in same patients.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Other: SMAD4 expression and methylation
Effect of SMAD4 methylations on smad4 expression
- Detection of SMAD4 methylations and expression [ Time Frame: 2 years ]Detection of SMAD4 methylations on tumor tissues
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): NCT04759261
|Contact: Yildiz Gursel, MD||90 505 537 30 email@example.com|
|Edirne, Turkey, 22000|
|Contact: Yildiz Gursel, MD +905055373063 firstname.lastname@example.org|
|Principal Investigator: Metin Budak, PhD|
|Principal Investigator: Fatma El Ustrali Keskin, MD|
|Principal Investigator:||Metin Budak||Trakya University|
|Principal Investigator:||Fatma El Usturali Keskin, MD||Trakya University|
|Study Director:||Yildiz Gursel, MD||Trakya University|