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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06448936
Other study ID # 6722
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 3, 2024
Est. completion date September 30, 2025

Study information

Verified date May 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Andrea Paradisi
Phone +393341904483
Email andrea.paradisi@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

FACE-QoL is an observational, prospective, multicenter study to evaluate the impact of surgical treatment on Quality of Life in patients with stage IIA and IIIB difficult-to-treat basal cell carcinoma of the face, according to the European Academy of Dermato Oncology classification, using Patient Reported Outcomes. The main questions it aims to answer are: - Surgery, as a gold standard for treatment, can lead to an improvement in patients' quality of life in difficult-to-treat basal cell carcinoma in functionally and cosmetically challenging sites of the face (i.e., stage IIA and IIIB) - Identify which clinical and individual variables have the greatest impact on patients' quality of life. Participants will answer questionnaires about quality of life and the impact of the disease on their lives.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 750
Est. completion date September 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical or histological diagnosis of difficult-to-treat basal cell carcinoma (DTT-BCC) classified as stage IIA or IIIB according to the EADO classification; - Location of the tumor: face. - Intervention: surgical treatment of facial stage IIA and IIIB difficult-to-treat basal cell carcinoma - A good patient's knowledge of spoken and written Italian. Exclusion Criteria: - Known psychiatric or substance abuse disorders that would interfere with cooperation and compliance with the requirements of the trial; - Inoperable or metastatic difficult-to-treat basal cell carcinoma - Contraindications to surgery related to the patient's condition; - Previous radiation therapy that involved the field of the target lesion

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient-reported outcome measures (PROMs)
Administration of questionnaires investigating the impact of facial difficult-to-treat basal cell carcinoma treated by surgery on patient's quality of life over the course of one year. The questionnaires will be submitted at baseline (i.e., before surgery) and at 3-months follow up.

Locations

Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Roma

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surgery in difficult-to-treat basal cell carcinoma The primary outcome is to assess the change in quality of life in patients with DTT-BCC of the face (stage IIA and IIIB of EADO classification) before and after surgery as measured by different questionnaire (i.e., GHQ-12, Skindex-17, SCI, PRISM) 1 year
Secondary Predictive variables A secondary endpoint is to identify which clinical and individual variables have the greatest impact on patients' quality of life (i.e., age, gender, tumor site or size, primary vs recurrent, type of reconstruction, etc) 1 year
Secondary Validation of the NAFEQ score A secondary endpoint is to validate the italian version of the NAFEQ score to evaluate the impact of surgery on QoL for DTT-BCCs of the nose (including different nasal subunits, i.e., dorsum, ala, side wall, tip, etc) 1 year
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