Dermatological TumorsNCT05267691
Pathological Characteristics of Basal Cell Carcinoma
An observational study of Dermatological Tumors, run by Al-Azhar University at 1 site in Egypt.
Trial summary
A hospital based cross-sectional study was conducted from 2017 to February 2021. Clinical history, examination and histopathological variants were collected from medical files and pathology reports. Read more about this study
- Who is it for?
- Ages 10 to 100 years
- Conditions the study is for
- Dermatological Tumors
- What is being tested?
- Excision
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 20 Oct 2022
- 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 10 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Visiting dermatology or surgery clinics in the tertiary hospital
Who may be able to join
- Excised lesion
- Confirmed basal cell carcinoma pathologically
Who cannot join
- Incision biopsy
- Incomplete follow up
Trial locations and contacts
1 site in 1 country.
Abdulkarim Hasan, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Abdulkarim Hasan
Cairo, 11884
Abdulkarim A Mohammed, 01281982245
About this study
Official title: Basal Cell Carcinomas on Sun-protected Versus Sun-exposed Body Sites: a Clinicopathological Descriptive Study
A hospital based cross-sectional study was conducted from 2017 to February 2021. Clinical history, examination and histopathological variants were collected from medical files and pathology reports. Confirmation of pathology was done in all the patients visiting skin and plastic surgery department with suspected lesions.
Read the detailed description
Some cases may be tested for immunohistochemistry on the tissue block
- Conditions
- Dermatological Tumors
- Being tested
- Excision
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExcisionProcedure or surgery
Surgical excision of the lesion and histopathology evaluation using Hematoxylin and Eosin stains
| Study group | Role | What they receive |
|---|---|---|
| sun-protected | All patients with basal cell carcinoma in a sun protected body site Receives: Procedure: Excision | |
| sun-exposed | All patients with basal cell carcinoma in a sun exposed body site Receives: Procedure: Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
Complete removal of the lesion
Measured: 1 day
Secondary outcomes (1)
Recurrence
Occurrence of recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Jan 2017
- Primary completion20 Mar 2022
- Study completion20 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatological TumorsStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkarim Hasan, Al-Azhar University
- Investigators
- Abdulkarim Hasan, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267691
- Sponsor's protocol ID
- AUH2201002
- Status last verified
- Jul 2022
- First submitted
- 24 Feb 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Cell Carcinomas on Sun-protected Versus Sun-exposed Body Sites: a Clinicopathological Descriptive Study
- ClinicalTrials.gov ID
- NCT05267691
- Acronym / sponsor ID
- AUH2201002
- Conditions
- Dermatological Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Oct 2022 (estimated)
- First posted
- 4 Mar 2022 (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.
A hospital based cross-sectional study was conducted from 2017 to February 2021. Clinical history, examination and histopathological variants were collected from medical files and pathology reports. Confirmation of pathology was done in all the patients visiting skin and plastic surgery department with suspected lesions.
Detailed description
Some cases may be tested for immunohistochemistry on the tissue block
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sun-protected | – | Procedure: ExcisionAll patients with basal cell carcinoma in a sun protected body site |
| sun-exposed | – | Procedure: ExcisionAll patients with basal cell carcinoma in a sun exposed body site |
Who may qualify
- Ages
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Visiting dermatology or surgery clinics in the tertiary hospital
Key inclusion criteria (2 listed)
- Excised lesion
- Confirmed basal cell carcinoma pathologically
Key exclusion criteria (2 listed)
- Incision biopsy
- Incomplete follow up
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 |
|---|---|---|
| ExcisionSurgical excision of the lesion and histopathology evaluation using Hematoxylin and Eosin stains | Procedure or surgery | sun-exposed, sun-protected |
Primary outcome
Healing
Time frame: 1 day
Complete removal of the lesion
1 secondary outcome
Recurrence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Abdulkarim Hasan, MD contact
Abdulkarim Hasan principal investigator
Al-Azhar University
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 Dermatological Tumors, run by Al-Azhar 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 2 inclusion and 2 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 20 Jul 2022. 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 Abdulkarim Hasan, MD (doctorabdulkarim7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: 1 day). 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 20 Jul 2022.