Clinical trial NCT06309836: Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma
Official title: Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Basal Cell Carcinoma
Lead sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with advanced basal cell carcinoma of the skin

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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical evolution, treatment and prognosis
timeFrame: from baseline through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Irccs Fondazione Policlinico Gemelli
state: ITA
Study officials:
affiliation: IRCCS FONDAZIONE POLICLINICO GEMELLI
name: Ketty MD Peris
role: PRINCIPAL_INVESTIGATOR
References: