Basal Cell CarcinomaREGISTRO-BCCNCT06309836
Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma
An observational study of Basal Cell Carcinoma, run by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
Trial summary
Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jun 2021to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with advanced basal cell carcinoma of the skin
Who may be able to join
- Male and female patients aged ≥ 18 years
- Patients diagnosed with advanced basal cell carcinoma of the skin, i.e. tumours included in at least one of the following categories: locally advanced carcinoma (not radically treatable by surgery and/or radiotherapy), carcinoma with lymph node and/or distant metastatic localisation
- patients who have had at least one access (first visit or follow-up visit) at the dermatology or oncology outpatient clinic of the centres involved
- Patients diagnosed with advanced BCC who have accessed the centre from 1 January 2016 until the date of activation of the centre will be included in the retrospective cohort;
- Patients diagnosed with advanced BCC who have accessed the centre from the date of activation
- Signature of informed consent
Who cannot join
- Patients incapable of giving informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Irccs Fondazione Policlinico Gemelli
Roma, ITA, 00168
peris MD Peris, 0630154211, ketty.peris@unicatt.it
About this study
Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma.
Read the detailed description
Basal cell carcinoma (BCC) is an epithelial tumor characterized by the malignant proliferation of keratinocytes in the basal layer of the epidermis. It is part, along with squamous cell carcinoma (SCC),non-melanoma skin cancer (NMSC) and accounts for 80% of all skin cancers and the most common skin cancer in the United States and Europe. Estimates of BCC incidence, however, are inaccurate since in most countries there is no cancer register collecting data on BCC incidence and many patients are treated on a territorial outpatient basis, making data collection and epidemiological analysis complex. In recent decades, there has been an increasing trend in patients with BCC, as well as a reduction in the average age of onset, with a consequent drastic increase in the social and economic cost of healthcare facilities. From these considerations, arises the need to investigate and characterize the profile of patients with advanced BCC, the clinical characteristics and the course of such neoplasm, and the choice of therapeutic options available.
- Conditions
- Basal Cell Carcinoma
- Medical subject headings
- Carcinoma, Basal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evolution, treatment and prognosis
clinical profile of patient, the phenotypic and behavioural characteristic and the clinical course from baseline to follow-up.
Measured: from baseline through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start23 Jun 2021
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
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.
- 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
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketty MD Peris, Principal investigator, IRCCS FONDAZIONE POLICLINICO GEMELLI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309836
- Sponsor's protocol ID
- SID03
- Acronym
- REGISTRO-BCC
- Status last verified
- Jun 2025
- First submitted
- 4 Aug 2023
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06309836
- Acronym / sponsor ID
- REGISTRO-BCC / SID03
- Conditions
- Basal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente TrasmesseUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Mar 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.
Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma.
Detailed description
Basal cell carcinoma (BCC) is an epithelial tumor characterized by the malignant proliferation of keratinocytes in the basal layer of the epidermis. It is part, along with squamous cell carcinoma (SCC),non-melanoma skin cancer (NMSC) and accounts for 80% of all skin cancers and the most common skin cancer in the United States and Europe. Estimates of BCC incidence, however, are inaccurate since in most countries there is no cancer register collecting data on BCC incidence and many patients are treated on a territorial outpatient basis, making data collection and epidemiological analysis complex. In recent decades, there has been an increasing trend in patients with BCC, as well as a reduction in the average age of onset, with a consequent drastic increase in the social and economic cost of healthcare facilities. From these considerations, arises the need to investigate and characterize the profile of patients with advanced BCC, the clinical characteristics and the course of such neoplasm, and the choice of therapeutic options available.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with advanced basal cell carcinoma of the skin
Key inclusion criteria (6 listed)
- Male and female patients aged ≥ 18 years
- Patients diagnosed with advanced basal cell carcinoma of the skin, i.e. tumours included in at least one of the following categories: locally advanced carcinoma (not radically treatable by surgery and/or radiotherapy), carcinoma with lymph node and/or distant metastatic localisation
- patients who have had at least one access (first visit or follow-up visit) at the dermatology or oncology outpatient clinic of the centres involved
- Signature of informed consent
Key exclusion criteria (1 listed)
- Patients incapable of giving informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical evolution, treatment and prognosis
Time frame: from baseline through study completion, an average of 3 years
clinical profile of patient, the phenotypic and behavioural characteristic and the clinical course from baseline to follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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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.
Ketty MD Peris principal investigator
IRCCS FONDAZIONE POLICLINICO GEMELLI
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, run by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
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 6 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ketty MD Peris (0630154211, ketty.peris@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical evolution, treatment and prognosis (time frame: from baseline through study completion, an average of 3 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 12 Jun 2025.