Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma

Recruiting

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT06309836
• Lead Sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse

Brief Summary

Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma.

Detailed Description

Basal cell carcinoma (BCC) is an epithelial tumor characterized by the malignant proliferation of keratinocytes in the basal layer of the epidermis. It is part, along with squamous cell carcinoma (SCC),non-melanoma skin cancer (NMSC) and accounts for 80% of all skin cancers and the most common skin cancer in the United States and Europe. Estimates of BCC incidence, however, are inaccurate since in most countries there is no cancer register collecting data on BCC incidence and many patients are treated on a territorial outpatient basis, making data collection and epidemiological analysis complex. In recent decades, there has been an increasing trend in patients with BCC, as well as a reduction in the average age of onset, with a consequent drastic increase in the social and economic cost of healthcare facilities. From these considerations, arises the need to investigate and characterize the profile of patients with advanced BCC, the clinical characteristics and the course of such neoplasm, and the choice of therapeutic options available.

Study Timeline

• Study Start: 2021-06-23
• Study First Submitted: 2023-08-04
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-06-23
• Study Completion: 2024-06-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Male and female patients aged ≥ 18 years

2. Patients diagnosed with advanced basal cell carcinoma of the skin, i.e. tumours included in at least one of the following categories: locally advanced carcinoma (not radically treatable by surgery and/or radiotherapy), carcinoma with lymph node and/or distant metastatic localisation

3. patients who have had at least one access (first visit or follow-up visit) at the dermatology or oncology outpatient clinic of the centres involved

   • Patients diagnosed with advanced BCC who have accessed the centre from 1 January 2016 until the date of activation of the centre will be included in the retrospective cohort;
   • Patients diagnosed with advanced BCC who have accessed the centre from the date of activation

4. Signature of informed consent

Exclusion Criteria

Patients incapable of giving informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical evolution, treatment and prognosis	from baseline through study completion, an average of 3 years	clinical profile of patient, the phenotypic and behavioural characteristic and the clinical course from baseline to follow-up.

Trial Locations

Locations (1)

Irccs Fondazione Policlinico Gemelli; 🇮🇹 Roma, ITA, Italy