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NCT Number: NCT06309836

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs Fondazione Policlinico Gemelli

Roma, ITA, 00168, Italy

Location status: Recruiting

Location contact

peris MD Peris

CONTACT

[email protected]

0630154211

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. clinical evolution, treatment and prognosis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ketty MD Peris

CONTACT

[email protected]

0630154211

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: REGISTRO-BCC

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Mar 13, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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