SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity

Basal Cell Carcinoma Clinical Trial

Official title:

SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759261
• Other study ID #: 2020/55
• Secondary ID: SMAD4
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Trakya University
• Contact: Yildiz Gursel, MD
• Phone: 90 505 537 30 63
• Email: yildizgrsl[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. People diagnosed clinically and dermoscopically with non-melanocytic skin cancer

2. No other cancer history

3. over 18 years old

4. Newly diagnosed

5. No systemic or topical therapy

Exclusion Criteria:

1. Under 18 and pregnant

2. People with non-melanocytic skin cancer who are in the process of follow-up and treatment

3. has another cancer history

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Skin Neoplasms

Intervention

Other:
• SMAD4 expression and methylation
Effect of SMAD4 methylations on smad4 expression

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of SMAD4 methylations and expression	Detection of SMAD4 methylations on tumor tissues	2 years