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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04759261
Enrollment
75
Registered
2021-02-18
Start date
2020-12-01
Completion date
2022-12-31
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

Keywords

Basal Cell Carcinoma, Squamose Cell Carcinoma, Actinic Keratoses, SMAD4 methylation, SMAD4 expression

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.

Interventions

OTHERSMAD4 expression and methylation

Effect of SMAD4 methylations on smad4 expression

Sponsors

Trakya University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Differantiation of tumor tissues than normal tissues in same patients.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection of SMAD4 methylations and expression2 yearsDetection of SMAD4 methylations on tumor tissues

Countries

Turkey (Türkiye)

Contacts

Primary ContactYildiz Gursel, MD
yildizgrsl@gmail.com90 505 537 30 63

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026