Quality of Life in Patients With Difficult-to-Treat Basal Cell Carcinoma: An Evaluation of Impact and Surgical Outcomes.

NCT ID: NCT06448936

Last Updated: 2025-04-03

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

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-03

Study Completion Date

2025-09-30

Brief Summary

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FACE-QoL is an observational, prospective, multicenter study aimed at evaluating 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 the study seeks to answer are:

Can surgery, as the gold standard treatment, lead to an improvement in the quality of life of patients with difficult-to-treat basal cell carcinoma in functionally and cosmetically challenging sites of the face (i.e., stage IIA and IIIB)? Which clinical and individual variables have the greatest impact on patients' quality of life? Participants will complete questionnaires assessing their quality of life and the impact of the disease on their daily lives.

Detailed Description

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Conditions

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Basal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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GHQ-12 Questionnaire Skindex-17 Questionnaire PRISM Questionnaire NAFEQ Questionnaire Skin Cancer Index Questionnaire

Eligibility Criteria

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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.
* Tumor location: face.
* Intervention: surgical treatment of facial stage IIA and IIIB difficult-to-treat basal cell carcinoma.
* Sufficient knowledge of spoken and written Italian by the patient.

Exclusion Criteria

* Known psychiatric or substance abuse disorders that may interfere with cooperation and compliance with trial requirements.
* Inoperable or metastatic difficult-to-treat basal cell carcinoma.
* Contraindications to surgery related to the patient's condition.
* Previous radiation therapy involving the field of the target lesion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Paradisi

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Paradisi

Role: CONTACT

+393341904483

Arianna Meoni

Role: CONTACT

+393202347290

Facility Contacts

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Andrea Paradisi

Role: primary

+393341904483

Other Identifiers

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6722

Identifier Type: -

Identifier Source: org_study_id

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