SMAD4 Methylation and Expression Levels in Non-melanocyti... | NCT04759261

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

NCT04759261

Sponsor

Trakya University

Status

Unknown status

Last Update Posted

Feb 18, 2021Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Basal Cell Carcinoma

Interventions

SMAD4 expression and methylation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SMAD4	Other Identifier	Trakya University

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Feb 9, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2021

Last Update Posted Date

Feb 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Other		Other: SMAD4 expression and methylation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SMAD4 expression and methylation	Other	Effect of SMAD4 methylations on smad4 expression	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of SMAD4 methylations and expression	Detection of SMAD4 methylations on tumor tissues	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yildiz Gursel, MD	Contact	90 505 537 30 63		yildizgrsl@gmail.com

Overall Officials

Name	Affiliation	Role
Metin Budak	Trakya University	Principal Investigator
Fatma El Usturali Keskin, MD	Trakya University	Principal Investigator
Yildiz Gursel, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Trakya University	Recruiting	Edirne		22000	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37428273	Derived	Gursel Urun Y, Budak M, Usturali Keskin E. Methylation status, mRNA and protein expression of the SMAD4 gene in patients with non-melanocytic skin cancers. Mol Biol Rep. 2023 Sep;50(9):7295-7304. doi: 10.1007/s11033-023-08656-2. Epub 2023 Jul 10.

ID	Term
D002280	Carcinoma, Basal Cell
D055623	Keratosis, Actinic

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D000478	Alkylation
D001669	Biochemical Phenomena
D055598	Chemical Phenomena
D055601	Organic Chemistry Phenomena