Basal Cell CarcinomaFACE-QOLNCT06448936
Quality of Life in Patients With Difficult-to-Treat Basal Cell Carcinoma: An Evaluation of Impact and Surgical Outcomes.
An observational study of Basal Cell Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Patient-reported outcome measures (PROMs)
- How many people
- 750 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sequential recruitment of patients undergoing surgery for difficult-to-treat basal cell carcinoma of the face in stage IIA or IIIB, according to the European Association of Dermato-Oncology (EADO) classification.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Andrea Paradisi, +393341904483, andrea.paradisi@policlinicogemelli.it
About this study
Official title: Assessment of Quality of Life in Patients Undergoing Surgery for Difficult-to-treat Basal Cell Carcinoma of the Face in Stage IIA or IIIB According to the European Association of Dermato-Oncology Classification.
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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Patient-reported outcome measures (PROMs)
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-reported outcome measures (PROMs)Other
Also called GHQ-12 Questionnaire, Skindex-17 Questionnaire, PRISM Questionnaire, NAFEQ Questionnaire
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery in difficult-to-treat basal cell carcinoma
The primary outcome is to assess the change in quality of life in patients with difficult-to-treat basal cell carcinoma (DTT-BCC) of the face (stage IIA and IIIB according to the European Association of Dermato-Oncology classification) before and after surgery, as measured by various questionnaires.
Measured: 1 year
Secondary outcomes (2)
Predictive variables
A secondary endpoint is to identify which clinical and individual variables have the greatest impact on patients' quality of life (e.g., age, gender, tumor site or size, primary vs. recurrent, type of reconstruction, etc.).
Measured: 1 year
Validation of the NAFEQ score.
A secondary endpoint is to validate the Italian version of the NAFEQ score (Nasal Appearance and Function Evaluation Questionnaire) to assess the impact of surgery on quality of life in patients with DTT-BCCs of the nose (including various nasal subunits, such as the dorsum, ala, side wall, tip, etc.). The questionnaire consists of 14 questions directed to patients, with a total score ranging from 18 to 66, where a score of 66 indicates post-surgical clinical and aesthetic improvement.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start3 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Paradisi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448936
- Sponsor's protocol ID
- 6722
- Acronym
- FACE-QOL
- Status last verified
- May 2024
- First submitted
- 4 Jun 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life in Patients Undergoing Surgery for Difficult-to-treat Basal Cell Carcinoma of the Face in Stage IIA or IIIB According to the European Association of Dermato-Oncology Classification.
- ClinicalTrials.gov ID
- NCT06448936
- Acronym / sponsor ID
- FACE-QOL / 6722
- Conditions
- Basal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sequential recruitment of patients undergoing surgery for difficult-to-treat basal cell carcinoma of the face in stage IIA or IIIB, according to the European Association of Dermato-Oncology (EADO) classification.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-reported outcome measures (PROMs)Also: GHQ-12 Questionnaire, Skindex-17 Questionnaire, PRISM Questionnaire, NAFEQ QuestionnaireAdministration 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. | Other | – |
Primary outcome
Surgery in difficult-to-treat basal cell carcinoma
Time frame: 1 year
The primary outcome is to assess the change in quality of life in patients with difficult-to-treat basal cell carcinoma (DTT-BCC) of the face (stage IIA and IIIB according to the European Association of Dermato-Oncology classification) before and after surgery, as measured by various questionnaires.
2 secondary outcomes
Predictive variables
Time frame: 1 year
Validation of the NAFEQ score.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Paradisi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Paradisi (+393341904483, andrea.paradisi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery in difficult-to-treat basal cell carcinoma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.