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Recruiting NCT06309836

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

Observational Basal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Basal Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • clinical evolution, treatment and prognosis [Time frame: from baseline through study completion, an average of 3 years]

Eligibility criteria

Inclusion criteria

  • Male and female patients aged ≥ 18 years
  • 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
  • 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
  • Signature of informed consent

Exclusion criteria

Patients incapable of giving informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Irccs Fondazione Policlinico Gemelli — Roma

Identifiers

NCT: NCT06309836 · SID03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗