Clinical trial NCT04759261: SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
Official title: SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Basal Cell Carcinoma
Keywords: Basal Cell Carcinoma
Squamose Cell Carcinoma
Actinic Keratoses
SMAD4 methylation
SMAD4 expression
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Differantiation of tumor tissues than normal tissues in same patients.
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Detection of SMAD4 methylations and expression
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
affiliation: Trakya University
name: Metin Budak
role: PRINCIPAL_INVESTIGATOR
affiliation: Trakya University
name: Fatma El Usturali Keskin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Trakya University
name: Yildiz Gursel, MD
role: STUDY_DIRECTOR
References: