Basal Cell CarcinomaNCT04759261
SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
A study testing SMAD4 expression and methylation in people with Basal Cell Carcinoma, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- SMAD4 expression and methylation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under 18 and pregnant
- People with non-melanocytic skin cancer who are in the process of follow-up and treatment
- has another cancer history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trakya University
Edirne, 22000
Yildiz Gursel, MD, +905055373063, ygurselu@gmail.com
Metin Budak, PhD
About this study
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.
Read more
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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- SMAD4 expression and methylation
- Keywords
- Basal Cell Carcinoma, Squamose Cell Carcinoma, Actinic Keratoses, SMAD4 methylation, SMAD4 expression
- Medical subject headings
- Carcinoma, Basal Cell, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMAD4 expression and methylationOther
Effect of SMAD4 methylations on smad4 expression
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | Not described Receives: Other: SMAD4 expression and methylation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of SMAD4 methylations and expression
Detection of SMAD4 methylations on tumor tissues
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Differantiation of tumor tissues than normal tissues in same patients.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metin Budak, Trakya University
- Investigators
- Metin Budak, Principal investigator, Trakya UniversityFatma El Usturali Keskin, MD, Principal investigator, Trakya UniversityYildiz Gursel, MD, Study director, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759261
- Sponsor's protocol ID
- 2020/55
- Other IDs
- SMAD4
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37428273
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
- ClinicalTrials.gov ID
- NCT04759261
- Acronym / sponsor ID
- 2020/55
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal Cell Carcinoma, Squamose Cell Carcinoma, Actinic Keratoses, SMAD4 methylation, SMAD4 expression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Differantiation of tumor tissues than normal tissues in same patients.
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Other: SMAD4 expression and methylation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Under 18 and pregnant
- People with non-melanocytic skin cancer who are in the process of follow-up and treatment
- has another cancer history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMAD4 expression and methylationEffect of SMAD4 methylations on smad4 expression | Other | Study group |
Primary outcome
Detection of SMAD4 methylations and expression
Time frame: 2 years
Detection of SMAD4 methylations on tumor tissues
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 37428273Gursel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Metin Budak principal investigator
Trakya University
Fatma El Usturali Keskin, MD principal investigator
Trakya University
Yildiz Gursel, MD study director
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMAD4 expression and methylation in people with Basal Cell Carcinoma, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yildiz Gursel, MD (90 505 537 30 63, yildizgrsl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of SMAD4 methylations and expression (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.