Basal Cell CarcinomaBASIXNCT07571031
Inter-Operator Variability in the Clinical Staging and Therapeutic Management of Basal Cell Carcinoma
An observational study of Basal Cell Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Basal cell carcinoma (BCC) is the most frequent skin cancer in humans, primarily located in sun-exposed areas. The incidence of BCC increases with cumulative exposure to ultraviolet (UV) radiation and is particularly high in the elderly population, with a reported peak around 80 years of age. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Dermatological evaluation
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2026to 20 Jun 2026
- 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: The included case will consist of adult patients ≥ 18 years, with histologically confirmed BCC, representing the full EADO spectrum (Stage IIA→ IIIC) and well-quality diagnostic image (blurry, under/overexposed, wrong lesion will be excluded). A total of 20 physicians from Policlinico Gemelli will be interviewed: 4 dermatologists, 4 plastic surgeons, 4 maxillofacial surgeons, 4 oncologists, and 4 radiotherapists.
Who may be able to join
- adult patients ≥ 18 years,
- histologically confirmed BCC, representing the full EADO spectrum (Stage IIA→ IIIC) and well-quality diagnostic image.
- Licensed medical doctors practicing in one of the target specialties: Dermatology, Plastic Surgery, Maxillofacial Surgery, Medical Oncology, or Radiotherapy.
- Currently involved in clinical management of BCC
- Able to provide informed consent for participation.
- Willing and able to complete the online questionnaire within the study timeframe.
- Minimum clinical experience: ≥ 1 year after specialty certification
Who cannot join
- not diagnosed BCC cases
- patients <18 years
- clinical experience <1 year after specialty certification
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Basal cell carcinoma (BCC) is the most frequent skin cancer in humans, primarily located in sun-exposed areas. The incidence of BCC increases with cumulative exposure to ultraviolet (UV) radiation and is particularly high in the elderly population, with a reported peak around 80 years of age. The new EADO classification distinguishes BCCs as 'easy-to-treat' and 'difficult-to-treat', subdivided into stages I-IV, with the aim of guiding therapeutic choices.
However, in clinical practice, there is marked variability among specialists in classification and treatment selection, with potential implications for clinical outcomes. This study aims to investigate inter-operator variability in both classification and therapeutic decisions for BCC. Specifically, it analyzes how specialists from different disciplines-dermatologists, oncologists, plastic surgeons, maxillofacial surgeons, and radiation therapists-and with varying clinical experience in BCC management approach the same clinical cases.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Dermatological evaluation
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermatological evaluationOther
Administration of three questionnaires to different groups of physicians to evaluate clinical staging and treatment decisions
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-operator variability in the BCC classification
Assess the inter-operator variability in BCC classification (EADO staging system) for the treatment decisions
Measured: 15 days
Secondary outcomes (2)
The impact of the therapeutic choices
Examine if patient-related factors such as age, comorbidities, tumor site, tumor dimension and comorbidities may impact on the therapeutic choices across different specialties.
Measured: 15 days
Evaluation of answers between different specialists
Evaluate how specialists in the same field with different clinical background (dermatologists, oncologists, maxillofacial surgeons, radiotherapists, plastic surgeons ) and experience (low defined as 1-10 years -moderate:10-20-high: >20) on skin tumors answer the questionnaire
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start11 May 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion20 Jun 2026 (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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Paradisi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571031
- Sponsor's protocol ID
- 27260
- Acronym
- BASIX
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-Operator Variability in the Clinical Staging and Therapeutic Management of Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07571031
- Acronym / sponsor ID
- BASIX / 27260
- Conditions
- Basal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 11 May 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 6 May 2026 (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.
Basal cell carcinoma (BCC) is the most frequent skin cancer in humans, primarily located in sun-exposed areas. The incidence of BCC increases with cumulative exposure to ultraviolet (UV) radiation and is particularly high in the elderly population, with a reported peak around 80 years of age. The new EADO classification distinguishes BCCs as 'easy-to-treat' and 'difficult-to-treat', subdivided into stages I-IV, with the aim of guiding therapeutic choices.
However, in clinical practice, there is marked variability among specialists in classification and treatment selection, with potential implications for clinical outcomes. This study aims to investigate inter-operator variability in both classification and therapeutic decisions for BCC. Specifically, it analyzes how specialists from different disciplines-dermatologists, oncologists, plastic surgeons, maxillofacial surgeons, and radiation therapists-and with varying clinical experience in BCC management approach the same clinical cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The included case will consist of adult patients ≥ 18 years, with histologically confirmed BCC, representing the full EADO spectrum (Stage IIA→ IIIC) and well-quality diagnostic image (blurry, under/overexposed, wrong lesion will be excluded). A total of 20 physicians from Policlinico Gemelli will be interviewed: 4 dermatologists, 4 plastic surgeons, 4 maxillofacial surgeons, 4 oncologists, and 4 radiotherapists.
Key inclusion criteria (7 listed)
- adult patients ≥ 18 years,
- histologically confirmed BCC, representing the full EADO spectrum (Stage IIA→ IIIC) and well-quality diagnostic image.
Key exclusion criteria (3 listed)
- not diagnosed BCC cases
- patients <18 years
- clinical experience <1 year after specialty certification
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 |
|---|---|---|
| Dermatological evaluationAdministration of three questionnaires to different groups of physicians to evaluate clinical staging and treatment decisions | Other | – |
Primary outcome
Inter-operator variability in the BCC classification
Time frame: 15 days
Assess the inter-operator variability in BCC classification (EADO staging system) for the treatment decisions
2 secondary outcomes
The impact of the therapeutic choices
Time frame: 15 days
Evaluation of answers between different specialists
Time frame: 15 days
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 6 May 2026.
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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.
Andrea Paradisi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 7 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: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Andrea Paradisi (+390630155701, andrea.paradisi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-operator variability in the BCC classification (time frame: 15 days). 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 May 2026; AzTrials last refreshed its copy on 4 Nov 2026.