ImmunosuppressionNCT02221843
Sunbit UV Measuring Device to Track Sun Behavior
An observational study of Immunosuppression and Skin Neoplasms, run by University of Zurich at 1 site in Switzerland.
Trial summary
Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of this study is to track sun behavior of patients at high risk for skin cancer, to investigate the feasibility of this prototype in daily life and to investigate the technical accuracy of the Sunbit. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Immunosuppression, Skin Neoplasms
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2014to Mar 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Department of Dermatology of the University Hospital Zurich
Who may be able to join
- Age ≥ 18 years
- History of skin cancer (melanoma or NMSC) or patients with high risk of skin cancer (e.g. immunosuppressive therapy)
- Oral and written informed consent
Who cannot join
- Any medical condition that renders the patient bedridden for the duration of 2 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology of the University Hospital Zurich
Zurich, 8091
About this study
Official title: An Observational Single Center Pilot Study Using a Wearable UV Sensor (Sunbit) Measuring UV Exposure of Patients at High Risk for Skin Cancer - SUNBIT Study
Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of this study is to track sun behavior of patients at high risk for skin cancer, to investigate the feasibility of this prototype in daily life and to investigate the technical accuracy of the Sunbit.
Read the detailed description
A total of 20 patients will be included to wear the Sunbit system during the time of 4 weeks. After this 4 weeks Sunbit will be recollected and data in the form of UV Indices will be extracted and analyzed.
Patients will be recruited in the Department of Dermatology of the University Hospital Zürich. The target population comprises patients with a high risk of melanoma and non-melanoma skin cancer, thus especially patients with an immunosuppressive therapy due to organ transplantation.
- Conditions
- Immunosuppression, Skin Neoplasms
- Keywords
- sun behavior, immunosuppression, skin neoplasms, sunbit, uv sensor, uv dosimeter, solar radiation, uv exposition, uv index
- Medical subject headings
- Skin Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days wearing the device
patient compliance
Measured: after 4 weeks wearing the device
Secondary outcomes (1)
difference between measured UV Indices and reference values
technical accuracy of the device
Measured: after 4 weeks wearing the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Company dissolved, no study devices available anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Günther Hofbauer, Prof. MD, Principal investigator, Department of Dermatology of the University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221843
- Sponsor's protocol ID
- KEK2013-0283_Sunbit
- Status last verified
- Jul 2016
- First submitted
- 19 Aug 2014
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: none intended
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Single Center Pilot Study Using a Wearable UV Sensor (Sunbit) Measuring UV Exposure of Patients at High Risk for Skin Cancer - SUNBIT Study
- ClinicalTrials.gov ID
- NCT02221843
- Acronym / sponsor ID
- KEK2013-0283_Sunbit
- Conditions
- Immunosuppression, Skin Neoplasms
- Keywords
- sun behavior, immunosuppression, skin neoplasms, sunbit, uv sensor, uv dosimeter, solar radiation, uv exposition
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Company dissolved, no study devices available anymore
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Aug 2014 (estimated)
- 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.
Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of this study is to track sun behavior of patients at high risk for skin cancer, to investigate the feasibility of this prototype in daily life and to investigate the technical accuracy of the Sunbit.
Detailed description
A total of 20 patients will be included to wear the Sunbit system during the time of 4 weeks. After this 4 weeks Sunbit will be recollected and data in the form of UV Indices will be extracted and analyzed.
Patients will be recruited in the Department of Dermatology of the University Hospital Zürich. The target population comprises patients with a high risk of melanoma and non-melanoma skin cancer, thus especially patients with an immunosuppressive therapy due to organ transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Dermatology of the University Hospital Zurich
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- History of skin cancer (melanoma or NMSC) or patients with high risk of skin cancer (e.g. immunosuppressive therapy)
- Oral and written informed consent
Key exclusion criteria (1 listed)
- Any medical condition that renders the patient bedridden for the duration of 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of days wearing the device
Time frame: after 4 weeks wearing the device
patient compliance
1 secondary outcome
difference between measured UV Indices and reference values
Time frame: after 4 weeks wearing the device
Results and safety
The study was stopped early (reason given: Company dissolved, no study devices available anymore). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Fahrni, T. Sundroid (renamed Sunbit): Solar Radiation Awareness with Smartphones. 2011Link provided by the sponsor.
- Individual participant dataSharing planned: No. none intended
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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.
Günther Hofbauer, Prof. MD principal investigator
Department of Dermatology of the University Hospital Zurich
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 Immunosuppression and Skin Neoplasms, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 13 Jul 2016. 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 Switzerland. 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?
The study was stopped early (reason given: Company dissolved, no study devices available anymore). 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?
number of days wearing the device (time frame: after 4 weeks wearing the device). 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 13 Jul 2016.