NCT04759261

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 9, 2021

Last Update Submit

February 16, 2021

Conditions

Basal Cell Carcinoma

Keywords

Basal Cell CarcinomaSquamose Cell CarcinomaActinic KeratosesSMAD4 methylationSMAD4 expression

Outcome Measures

Primary Outcomes (1)

  • Detection of SMAD4 methylations and expression

    Detection of SMAD4 methylations on tumor tissues

    2 years

Study Arms (1)

Study group

OTHER
Other: SMAD4 expression and methylation

Interventions

SMAD4 expression and methylationOTHER

Effect of SMAD4 methylations on smad4 expression

Study group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under 18 and pregnant
  • People with non-melanocytic skin cancer who are in the process of follow-up and treatment
  • has another cancer history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37428273DERIVED

MeSH Terms

Conditions

Carcinoma, Basal CellKeratosis, Actinic

Interventions

Methylation

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellPrecancerous ConditionsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AlkylationBiochemical PhenomenaChemical PhenomenaOrganic Chemistry PhenomenaMetabolism

Study Officials

  • Metin Budak

    Trakya University

    PRINCIPAL INVESTIGATOR

  • Fatma El Usturali Keskin, MD

    Trakya University

    PRINCIPAL INVESTIGATOR

  • Yildiz Gursel, MD

    Trakya University

    STUDY DIRECTOR

Central Study Contacts

Yildiz Gursel, MD

CONTACT

90 505 537 30 63yildizgrsl@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Differantiation of tumor tissues than normal tissues in same patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Prof. Dr.

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 18, 2021

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 31, 2022

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

TU(1)