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

NCT04759261 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-02-18

No results posted yet for this study

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.

Conditions

Interventions

OTHER

SMAD4 expression and methylation

Effect of SMAD4 methylations on smad4 expression

Sponsors & Collaborators

  • Trakya University

    lead OTHER

Principal Investigators

  • Metin Budak · Trakya University

  • Fatma El Usturali Keskin, MD · Trakya University

  • Yildiz Gursel, MD · Trakya University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-12-01
Completion
2022-12-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759261 on ClinicalTrials.gov