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

NCT07571031 | Not Yet Recruiting

• 1 other identifier: 27260
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

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

  15 days

Secondary Outcomes (2)

• The impact of the therapeutic choices

  15 days

• Evaluation of answers between different specialists

  15 days

Interventions

Dermatological evaluation OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• not diagnosed BCC cases
• patients \<18 years
• \- clinical experience \<1 year after specialty certification

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Paradisi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Paradisi

CONTACT

+390630155701; andrea.paradisi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04