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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

not diagnosed BCC cases

patients <18 years

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Dermatological evaluation

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Inter-operator variability in the BCC classification

Assess the inter-operator variability in BCC classification (EADO staging system) for the treatment decisions

Time frame
15 days

Secondary outcomes

1

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.

Time frame
15 days
2

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

Time frame
15 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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