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

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 Overview

• Status: Not yet recruiting
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Other: Dermatological evaluation

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Andrea Paradisi; Phone Number: +390630155701; Email: andrea.paradisi@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Exclusion Criteria for physicians:

- clinical experience <1 year after specialty certification

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-operator variability in the BCC classification	Assess the inter-operator variability in BCC classification (EADO staging system) for the treatment decisions	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	15 days

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Andrea Paradisi, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Basal Cell; Carcinoma, Basal Cell
• Other Study ID Numbers: 27260

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No