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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04759261
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
Metin Budak, Trakya University

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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Other: SMAD4 expression and methylation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Differantiation of tumor tissues than normal tissues in same patients.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Study group Other: SMAD4 expression and methylation
Effect of SMAD4 methylations on smad4 expression

Primary Outcome Measures :
  1. Detection of SMAD4 methylations and expression [ Time Frame: 2 years ]
    Detection of SMAD4 methylations on tumor tissues

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04759261

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Contact: Yildiz Gursel, MD 90 505 537 30 63

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Trakya University Recruiting
Edirne, Turkey, 22000
Contact: Yildiz Gursel, MD    +905055373063   
Principal Investigator: Metin Budak, PhD         
Principal Investigator: Fatma El Ustrali Keskin, MD         
Sponsors and Collaborators
Trakya University
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Principal Investigator: Metin Budak Trakya University
Principal Investigator: Fatma El Usturali Keskin, MD Trakya University
Study Director: Yildiz Gursel, MD Trakya University
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Responsible Party: Metin Budak, Asist. Prof. Dr., Trakya University Identifier: NCT04759261    
Other Study ID Numbers: 2020/55
SMAD4 ( Other Identifier: Trakya University )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Metin Budak, Trakya University:
Basal Cell Carcinoma
Squamose Cell Carcinoma
Actinic Keratoses
SMAD4 methylation
SMAD4 expression
Additional relevant MeSH terms:
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Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases