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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06309836
Other study ID # SID03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 23, 2021
Est. completion date June 23, 2024

Study information

Verified date March 2024
Source Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Contact Ketty MD Peris
Phone 0630154211
Email ketty.peris@unicatt.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date June 23, 2024
Est. primary completion date June 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Irccs Fondazione Policlinico Gemelli Roma ITA

Sponsors (1)

Lead Sponsor Collaborator
Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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