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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04814953
Other study ID # BC-5344
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


Description:

See protocol


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2400
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion criteria 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 1. Patient is younger than 18 years old or unable to provide consent. 2. Patient is unable to remember the diagnosis or symptoms of their KC or premalignant lesion upon request by the doctor. 3. Patient was diagnosed with a melanoma or another NMSC. 4. Patient is unable to understand the task and questionnaires.

Study Design


Intervention

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.

Locations

Country Name City State
Belgium Department of Dermatology, Ghent University Hospital Ghent
Netherlands MC Rotterdam Department of Dermatology Rotterdam

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Ghent Erasmus Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
Primary 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. 1 year
Primary 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. 1 year
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