Back to resultsSMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
Primary Purpose
Basal Cell Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SMAD4 expression and methylation
Sponsored by
About this trial
This is an interventional basic science trial for Basal Cell Carcinoma focused on measuring Basal Cell Carcinoma, Squamose Cell Carcinoma, Actinic Keratoses, SMAD4 methylation, SMAD4 expression
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Under 18 and pregnant
- People with non-melanocytic skin cancer who are in the process of follow-up and treatment
- has another cancer history
Sites / Locations
- Trakya UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study group
Arm Description
Outcomes
Primary Outcome Measures
Detection of SMAD4 methylations and expression
Detection of SMAD4 methylations on tumor tissues
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04759261
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
Basal Cell Carcinoma, Squamose Cell Carcinoma, Actinic Keratoses, SMAD4 methylation, SMAD4 expression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Differantiation of tumor tissues than normal tissues in same patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
SMAD4 expression and methylation
Intervention Description
Effect of SMAD4 methylations on smad4 expression
Primary Outcome Measure Information:
Title
Detection of SMAD4 methylations and expression
Description
Detection of SMAD4 methylations on tumor tissues
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Under 18 and pregnant
People with non-melanocytic skin cancer who are in the process of follow-up and treatment
has another cancer history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yildiz Gursel, MD
Phone
90 505 537 30 63
Email
yildizgrsl@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Metin Budak
Organizational Affiliation
Trakya University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatma El Usturali Keskin, MD
Organizational Affiliation
Trakya University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yildiz Gursel, MD
Organizational Affiliation
Trakya University
Official's Role
Study Director
Facility Information:
Facility Name
Trakya University
City
Edirne
ZIP/Postal Code
22000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yildiz Gursel, MD
Phone
+905055373063
Email
ygurselu@gmail.com
First Name & Middle Initial & Last Name & Degree
Metin Budak, PhD
First Name & Middle Initial & Last Name & Degree
Fatma El Ustrali Keskin, MD
12. IPD Sharing Statement
Learn more about this trial
SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
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