Cutaneous Squamous Cell CarcinomaNCT06536946
B-catenin in Cutaneous Squamous Cell Carcinoma and Its Mimickers
An observational study of Cutaneous Squamous Cell Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
Examine the role of B-catenin in differentiation of cutaneous squamous cell carcinoma from other lesions that may be similar to it Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Immunohistochemical staining
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Sep 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: archived formalin fixed parrafin embedded tissue pieces of patients of cutanous squamous cell carcinoma and its mimickers admitted to sohag University hospital from period juniory 2023 to June 2024
Who may be able to join
- tissue blocks with sufficient materials Cases with sufficient data
Who cannot join
- tissue blocks with insufficient and necrotic materials. Casas with insufficient data
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospital
Sohag
Magdy M Amen, Professor
Nermeen S Habeeb, Doctor, 01200496394, nermin.tharwat@med.sohag.edu.eg
About this study
Official title: Expression of B-catenin in Cutaneous Squamous Cell Carcinoma and Its Mimickers
Examine the role of B-catenin in differentiation of cutaneous squamous cell carcinoma from other lesions that may be similar to it
Read the detailed description
Skin cancer is one of the most common form of cancer worldwide. Cutaneous squamous cell carcinoma is one of most common skin tumers that caused by many factors as ultra violet ,ionizing radiation and others . It was an advanced spectrum ranging from actinic keratosis to invasive and metastatic squmous cell carcinoma. Correct identification of cutaneous squamous cell carcinoma is a challenge as it has both clinically and histopathologically mimickers.
So the aim of this study is to identify the expression of B-catenin in cutaneous Squamous cell carcinoma and its mimickers.
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- Immunohistochemical staining
- Keywords
- B-catenin, Cutaneous squamous cell carcinoma, Immunohistochemistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemical stainingBiological
Staining of cutanous squamous cell carcinoma and its mimickers by monoclonal antibodies against human B-catenin by immunohistochemical procedures
| Study group | Role | What they receive |
|---|---|---|
| Participants | 50 formalin fixed parrafin embedded tissue blocks of cutaneous squamous cell carcinoma and its mimickers , from each block 2 tissue section; one tissue section stained by Hematoxilin and Eoisin and other tissue section will be stained immunohistochemically by anti human B-catenin Receives: Biological: Immunohistochemical staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of B-catenin expression in cutanous squamous cell carcinoma and its mimickers
Detection of expression of B-catenin in cutaneous squamous cell carcinoma and its mimickers by immunohistochemical procedures using antihuman B-catenin monoclonal antibodies
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jun 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermin Sarwat Habib, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536946
- Sponsor's protocol ID
- Soh-Med-25-05-07MS
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of B-catenin in Cutaneous Squamous Cell Carcinoma and Its Mimickers
- ClinicalTrials.gov ID
- NCT06536946
- Acronym / sponsor ID
- Soh-Med-25-05-07MS
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Keywords
- B-catenin, Cutaneous squamous cell carcinoma, Immunohistochemistry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 5 Aug 2024 (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.
Examine the role of B-catenin in differentiation of cutaneous squamous cell carcinoma from other lesions that may be similar to it
Detailed description
Skin cancer is one of the most common form of cancer worldwide. Cutaneous squamous cell carcinoma is one of most common skin tumers that caused by many factors as ultra violet ,ionizing radiation and others . It was an advanced spectrum ranging from actinic keratosis to invasive and metastatic squmous cell carcinoma. Correct identification of cutaneous squamous cell carcinoma is a challenge as it has both clinically and histopathologically mimickers.
So the aim of this study is to identify the expression of B-catenin in cutaneous Squamous cell carcinoma and its mimickers.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Biological: Immunohistochemical staining50 formalin fixed parrafin embedded tissue blocks of cutaneous squamous cell carcinoma and its mimickers , from each block 2 tissue section; one tissue section stained by Hematoxilin and Eoisin and other tissue section will be stained immunohistochemically by anti human B-catenin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- archived formalin fixed parrafin embedded tissue pieces of patients of cutanous squamous cell carcinoma and its mimickers admitted to sohag University hospital from period juniory 2023 to June 2024
Key inclusion criteria (1 listed)
- tissue blocks with sufficient materials Cases with sufficient data
Key exclusion criteria (1 listed)
- tissue blocks with insufficient and necrotic materials. Casas with insufficient data
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 |
|---|---|---|
| Immunohistochemical stainingStaining of cutanous squamous cell carcinoma and its mimickers by monoclonal antibodies against human B-catenin by immunohistochemical procedures | Biological | Participants |
Primary outcome
Detection of B-catenin expression in cutanous squamous cell carcinoma and its mimickers
Time frame: 6 month
Detection of expression of B-catenin in cutaneous squamous cell carcinoma and its mimickers by immunohistochemical procedures using antihuman B-catenin monoclonal antibodies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Squamous Cell Carcinoma, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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 6 Aug 2024. 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 Egypt. 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 Nermeen S Habeeb, Doctor (01200496394, nermin.tharwat@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of B-catenin expression in cutanous squamous cell carcinoma and its mimickers (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.