An observational study in Basal Cell Carcinoma, Squamous Cell Carcinoma and Actinic Keratoses, sponsored by University Hospital, Ghent. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University Hospital, Ghent · Observational
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).
See protocol
369 studies on the registry are indexed under Carcinoma, Basal Cell; 65 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 138 across 92 observational studies indexed under Carcinoma, Basal Cell.
Browse Carcinoma, Basal Cell studies →University Hospital, Ghent is the lead sponsor of 685 studies on the registry; 158 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Patients with one or more premalignant lesion or KC diagnosed by a dermatologist or by histopathology untill 10 years previous to inclusion.
Exclusion criteria
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)
Other: questionnaires
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)
Other: questionnaires
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)
Other: questionnaires
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2020 (actual). Primary completion is estimated for Dec 2025, 65 months after the start.
Of 37 observational studies under Carcinoma, Basal Cell, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 72. This study's planned 65 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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