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Inter-Operator Variability in the Clinical Staging and Therapeutic Management of Basal Cell Carcinoma

Inter-Operator Variability in the Clinical Staging and Therapeutic Management of Basal Cell Carcinoma

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07571031
Acronym
BASIX
Enrollment
20
Registered
2026-05-06
Start date
2026-05-11
Completion date
2026-06-20
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

Brief 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. 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.

Interventions

Administration of three questionnaires to different groups of physicians to evaluate clinical staging and treatment decisions

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients ≥ 18 years, * histologically confirmed BCC, representing the full EADO spectrum (Stage IIA→ IIIC) and well-quality diagnostic image. * Inclusion criteria (physicians) * 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

Exclusion criteria

for patients: * not diagnosed BCC cases * patients \<18 years

Design outcomes

Primary

MeasureTime frameDescription
Inter-operator variability in the BCC classification15 daysAssess the inter-operator variability in BCC classification (EADO staging system) for the treatment decisions

Secondary

MeasureTime frameDescription
The impact of the therapeutic choices15 daysExamine if patient-related factors such as age, comorbidities, tumor site, tumor dimension and comorbidities may impact on the therapeutic choices across different specialties.
Evaluation of answers between different specialists15 daysEvaluate 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

Contacts

CONTACTAndrea Paradisi
andrea.paradisi@policlinicogemelli.it+390630155701
PRINCIPAL_INVESTIGATORAndrea Paradisi

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026