Basal Cell CarcinomaNCT05853315
BCC Excision Revisited
An observational study of Basal Cell Carcinoma and Eye Diseases, run by Medical University of Vienna at 1 site in Austria.
Trial summary
To readdress basal cell carcinoma (BCC) in the periocular region to prove histologically controlled surgical treatment efficacy and to identify high-risk characteristics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Basal Cell Carcinoma, Eye Diseases, Eye Cancer
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 451 participants
- Where
- 1 siteAustria
- Study dates
- 12 Nov 2019to 1 May 2023
- 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: male and female patients with periocular basal cell carcinoma
Who may be able to join
- Patient records were reviewed for the presence of BCC and surgical excision with frozen sections control of the wound margins in the periocular region,
- conducted between 01.01.2009 and 31.12.2019.
- Periocular was defined as the area involving the medial and lateral canthus as well as the upper and lower eyelids.
Who cannot join
- BCCs outside of this region were excluded from this analysis,
- as well as incomplete records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Results After Surgical Basal Cell Carcinoma Excision in the Eyelid Region: Revisited
To readdress basal cell carcinoma (BCC) in the periocular region to prove histologically controlled surgical treatment efficacy and to identify high-risk characteristics.
- Conditions
- Basal Cell Carcinoma, Eye Diseases, Eye Cancer
- Being tested
- Surgery
- Medical subject headings
- Carcinoma, Basal Cell, Eye Diseases, Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgical Excision
What is being measured
The primary outcome is the main question the study is designed to answer.
BCC Recurrence
Measured: mean 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start12 Nov 2019
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reinhard Told, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853315
- Sponsor's protocol ID
- 1997/2019
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Results After Surgical Basal Cell Carcinoma Excision in the Eyelid Region: Revisited
- ClinicalTrials.gov ID
- NCT05853315
- Acronym / sponsor ID
- 1997/2019
- Conditions
- Basal Cell Carcinoma, Eye Diseases, Eye Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 10 May 2023 (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.
To readdress basal cell carcinoma (BCC) in the periocular region to prove histologically controlled surgical treatment efficacy and to identify high-risk characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- male and female patients with periocular basal cell carcinoma
Key inclusion criteria (3 listed)
- Patient records were reviewed for the presence of BCC and surgical excision with frozen sections control of the wound margins in the periocular region,
- conducted between 01.01.2009 and 31.12.2019.
- Periocular was defined as the area involving the medial and lateral canthus as well as the upper and lower eyelids.
Key exclusion criteria (2 listed)
- BCCs outside of this region were excluded from this analysis,
- as well as incomplete records.
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 |
|---|---|---|
| SurgerySurgical Excision | Procedure or surgery | – |
Primary outcome
BCC Recurrence
Time frame: mean 3-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
Related trials for Basal Cell Carcinoma
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
Not yet recruiting
Plasmonic PhotoThermal Therapy (PPTT) With Glucose-Coated Gold Nanoparticles (TSK-001) in Patients With Nodular Basal Cell Carcinoma (nBCC)
Nodular BCC
RecruitingObservational study
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice
Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT)
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 2
Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Basal Cell Carcinoma and Eye Diseases, run by Medical University of Vienna at 1 site in Austria.
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 3 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: finished, as of the sponsor's last update on 16 May 2023. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCC Recurrence (time frame: mean 3-5 years). 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 16 May 2023.