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

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermatological evaluation

Other

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

Primary outcomes

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

Secondary outcomes

The impact of the therapeutic choices

Time frame: 15 days

Examine 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 specialists

Time frame: 15 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Paradisi

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: BASIX

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: May 6, 2026
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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