Basal Cell CarcinomaNCT04814953
HRQoL Keratinocyte Carcinomas
An observational study of Basal Cell Carcinoma and Squamous Cell Carcinoma, run by University Hospital, Ghent at 2 sites in 2 countries.
Trial summary
Rationale: Keratinocyte skin cancer is known to influence the HRQoL in a specific way. Derived utility values are required for cost-effectiveness analyses of new interventions. However there is no sensitive tool to capture HRQoL that translates into utilities available. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Actinic Keratoses
- What is being tested?
- questionnaires
- How many people
- 2,400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2020to 31 Dec 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at the Department of Dermatology of the University Hospital of Ghent and the Erasmus MC Rotterdam. In addition, patients in other hospitals and dermatology clinics will be asked to participate. Two general practitioners will also include patients with a KC or actinic keratoses.
Who may be able to join
- 1. Patients with one or more premalignant lesion or KC diagnosed by a dermatologist or by histopathology untill 10 years previous to inclusion.
Who cannot join
- Patient is younger than 18 years old or unable to provide consent.
- Patient is unable to remember the diagnosis or symptoms of their KC or premalignant lesion upon request by the doctor.
- Patient was diagnosed with a melanoma or another NMSC.
- Patient is unable to understand the task and questionnaires.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
Department of Dermatology, Ghent University Hospital
Ghent, 9000
About this study
Official title: HRQoL and Development of Health Utilities in Patients With Keratinocyte Carcinomas
Rationale: Keratinocyte skin cancer is known to influence the HRQoL in a specific way. Derived utility values are required for cost-effectiveness analyses of new interventions. However there is no sensitive tool to capture HRQoL that translates into utilities available.
Objective: To document the exact HRQoL in patients with in KC using the generic EQ-5D-5L questionnaire, as well as the TTO, 15D and the BaSQoL questionnaire, and to develop health utilities based on these tools.
Read more
Study design: Longitudinal observational study (at time 0 and time 0 +12 months).
Study population: Patients aged ≥18 years consulting a dermatologist or their GP for diagnosis, treatment or follow-up of a (pre)malignant skin lesion(s).
Read the detailed description
See protocol
- Being tested
- questionnaires
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
EQ-5D-5L questionnaire questioning their overall health on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In addition patients will have to fill in the generic 15D questioning 15 specific dimensions on 5 levels as well as the BaSQoL, which is a disease specific questionnaire for patients with KC. The Time-trade off task is the final question.
| Study group | Role | What they receive |
|---|---|---|
| Basal cell carinoma patients | Patients with basal cell carcinoma in history (up to 10 years before inclusion) with or without squamous cell carcinoma or actinic keratosis but no other skin cancers (melanoma or non-melanoma skin cancer) Receives: Other: questionnaires | |
| Squamous cell carcinoma patients | Patients with squamous cell carcinoma in history (up to 10 years before inclusion) with or without basal cell carcinoma or actinic keratosis but no other skin cancers (melanoma or non-melanoma skin cancer) Receives: Other: questionnaires | |
| Patients with actinic keratoses | Patients with actinic keratosis in history (up to 10 years before inclusion) with or without basal cell carcinoma or squamous cell carcinomas but no other skin cancers (melanoma or non-melanoma skin cancer) Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health utility (by using a time trade off questionnaire)
Utilities as determined by the time trade off, this is a technique used to measure the quality of life that a person or group is experiencing. An individual will be presented with a set of directions such as, and the result will be a health utility index between 0-1. Lower scores mean less HrQoL.
Measured: 1 year
Health utility (by using the 15D questionnaire)
Utilities as determined by the 15D questionnaire, a generic questionnaire developed to determine a health utility index between 0-1. Lower scores mean less HrQoL.
Measured: 1 year
Health utility (by using the EQ-5D-5L questionnaire)
Utilities as determined by the EQ-5D questionnaire, a generic questionnaire developed to determine a health utility index between 0-1. Lower scores mean less HrQoL.
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 posted24 Mar 2021
- Study start1 Jul 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Lieve Hoorens, MD, PhD, Principal investigator, Ghent University Hospital, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814953
- Sponsor's protocol ID
- BC-5344
- Status last verified
- May 2024
- First submitted
- 16 Jun 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HRQoL and Development of Health Utilities in Patients With Keratinocyte Carcinomas
- ClinicalTrials.gov ID
- NCT04814953
- Acronym / sponsor ID
- BC-5344
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Mar 2021 (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.
Rationale: Keratinocyte skin cancer is known to influence the HRQoL in a specific way. Derived utility values are required for cost-effectiveness analyses of new interventions. However there is no sensitive tool to capture HRQoL that translates into utilities available.
Objective: To document the exact HRQoL in patients with in KC using the generic EQ-5D-5L questionnaire, as well as the TTO, 15D and the BaSQoL questionnaire, and to develop health utilities based on these tools.
Study design: Longitudinal observational study (at time 0 and time 0 +12 months).
Study population: Patients aged ≥18 years consulting a dermatologist or their GP for diagnosis, treatment or follow-up of a (pre)malignant skin lesion(s).
Detailed description
See protocol
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basal cell carinoma patients | – | Other: questionnairesPatients with basal cell carcinoma in history (up to 10 years before inclusion) with or without squamous cell carcinoma or actinic keratosis but no other skin cancers (melanoma or non-melanoma skin cancer) |
| Squamous cell carcinoma patients | – | Other: questionnairesPatients with squamous cell carcinoma in history (up to 10 years before inclusion) with or without basal cell carcinoma or actinic keratosis but no other skin cancers (melanoma or non-melanoma skin cancer) |
| Patients with actinic keratoses | – | Other: questionnairesPatients with actinic keratosis in history (up to 10 years before inclusion) with or without basal cell carcinoma or squamous cell carcinomas but no other skin cancers (melanoma or non-melanoma skin cancer) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the Department of Dermatology of the University Hospital of Ghent and the Erasmus MC Rotterdam. In addition, patients in other hospitals and dermatology clinics will be asked to participate. Two general practitioners will also include patients with a KC or actinic keratoses.
Key inclusion criteria (1 listed)
- 1. Patients with one or more premalignant lesion or KC diagnosed by a dermatologist or by histopathology untill 10 years previous to inclusion.
Key exclusion criteria (4 listed)
- Patient is younger than 18 years old or unable to provide consent.
- Patient is unable to remember the diagnosis or symptoms of their KC or premalignant lesion upon request by the doctor.
- Patient was diagnosed with a melanoma or another NMSC.
- Patient is unable to understand the task and questionnaires.
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 |
|---|---|---|
| questionnairesEQ-5D-5L questionnaire questioning their overall health on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In addition patients will have to fill in the generic 15D questioning 15 specific dimensions on 5 levels as well as the BaSQoL, which is a disease specific questionnaire for patients with KC. The Time-trade off task is the final question. | Other | Basal cell carinoma patients, Patients with actinic keratoses, Squamous cell carcinoma patients |
Primary outcome
Health utility (by using a time trade off questionnaire)
Time frame: 1 year
Utilities as determined by the time trade off, this is a technique used to measure the quality of life that a person or group is experiencing. An individual will be presented with a set of directions such as, and the result will be a health utility index between 0-1. Lower scores mean less HrQoL.
Health utility (by using the 15D questionnaire)
Time frame: 1 year
Utilities as determined by the 15D questionnaire, a generic questionnaire developed to determine a health utility index between 0-1. Lower scores mean less HrQoL.
Health utility (by using the EQ-5D-5L questionnaire)
Time frame: 1 year
Utilities as determined by the EQ-5D questionnaire, a generic questionnaire developed to determine a health utility index between 0-1. Lower scores mean less HrQoL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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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.
Lieve Hoorens, MD, PhD principal investigator
Ghent University Hospital, Department of Dermatology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma and Squamous Cell Carcinoma, run by University Hospital, Ghent at 2 sites in 2 countries.
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 1 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health utility (by using a time trade off questionnaire) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 9 May 2024.