Quality of Life in Patients With Difficult-to-treat Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

— FACE-QOL  

Official title:

Quality of Life Assessment in Patients Undergoing Surgery for Difficult-to-treat Basal Cell Carcinoma of the Face in Stage IIA or IIIB According to the Classification of the European Association of Dermato Oncology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448936
• Other study ID #: 6722
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

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