Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma (REGISTRO-BCC)

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

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Ketty MD Peris; Phone Number: 0630154211; Email: ketty.peris@unicatt.it

Study Locations

• Italy
  • ITA
    • Roma, ITA, Italy, 00168
      • Recruiting
      • IRCCS Fondazione Policlinico Gemelli
      • Contact: peris MD Peris; Phone Number: 0630154211; Email: ketty.peris@unicatt.it

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with advanced basal cell carcinoma of the skin

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
• Investigators: Principal Investigator: Ketty MD Peris, IRCCS Fondazione Policlinico Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: SID03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No