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

NCT ID: NCT06309836

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-23

Study Completion Date

2029-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Basal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ketty MD Peris

Role: PRINCIPAL_INVESTIGATOR

IRCCS FONDAZIONE POLICLINICO GEMELLI

Locations

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Irccs Fondazione Policlinico Gemelli

Roma, ITA, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Ketty MD Peris

Role: CONTACT

0630154211

Facility Contacts

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peris MD Peris

Role: primary

0630154211

Other Identifiers

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SID03

Identifier Type: -

Identifier Source: org_study_id

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