跳至主要内容
临床试验/NCT04759261
NCT04759261Unknown不适用

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

Trakya University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
试验地点
2
主要终点
Detection of SMAD4 methylations and expression

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Under 18 and pregnant
  • People with non-melanocytic skin cancer who are in the process of follow-up and treatment
  • has another cancer history

结局指标

主要结局

Detection of SMAD4 methylations and expression

时间窗: 2 years

Detection of SMAD4 methylations on tumor tissues

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Metin Budak

Asist. Prof. Dr.

Trakya University

研究点 (2)

Loading locations...

相似试验