Skin CancerSCSTCSNCT02361229
Skin Cancer in Swiss Transplant Cohort Study
An observational study of Skin Cancer, run by University of Zurich at 1 site in Switzerland.
Trial summary
It's known that organ transplant recipients with long-term drug-induced immunosuppression have a increase of the life-time incidence of squamous cell carcinoma. This study will analyze the incidence and type of skin cancer in the Swiss Transplant Cohort Study and the association with exposure to immunosuppressive and… Read more about this study
- Who is it for?
- Ages 1 hour and older
- Conditions the study is for
- Skin Cancer
- How many people
- 4,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Dec 2019
- How long will I take part?
- 10 Years
- 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 1 hour and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Solid organ transplant recipients within the STCS.
Who may be able to join
- solid organ transplant recipients within the STCS
- patients with multiple organ transplantations will be included as well
- patients within the STCS, who gave the informed consent to use their data
- patients with graft loss will remain in the study, since they remain at risk of skin cancer development
Who cannot join
- organ transplant recipients of non-solid organs (e.g. hematopoetic stem cell transplantation) within the STCS
Trial locations and contacts
1 site in 1 country.
About this study
It's known that organ transplant recipients with long-term drug-induced immunosuppression have a increase of the life-time incidence of squamous cell carcinoma. This study will analyze the incidence and type of skin cancer in the Swiss Transplant Cohort Study and the association with exposure to immunosuppressive and antiinfective drugs and other parameters like age or gender of organ transplant recipients.
Read the detailed description
Organ transplant recipients with long-term drug-induced immunosuppression have an increase of the life-time incidence of squamous cell carcinoma and are also affected at an earlier age than the general population. In organ transplant recipients prognosis of squamous cell carcinoma differs due to more rapid growth, less differentiation and higher risk for metastases in comparison to the general population. Epidemiological data indicate that the risk of skin neoplasms in organ transplant recipients is related to the cumulative exposure to immunosuppressive drugs over time. It remains unclear wether this risk differs between drug classes.
This study is a prospective observational cohort study of kidney, heart, lung, liver, pancreas and small bowel transplant recipients enrolled into the Swiss Transplant Cohort Study (STCS).
Since 2008 almost all organ transplant recipients in Switzerland are enrolled to the STCS. The STCS collects
- baseline patient and case data: date of transplantation, age, gender, type of transplanted organ, past immunosuppression
- follow-up patient and case data: organ rejection with type and date of rejection, type of immunosuppression in response to organ rejection, graft loss with date of graft loss, immunosuppressive drug treatment, other drug treatment, death, drop out, occurrence of cancer and infections)
- drug exposure data (with start and stop dates): induction immunosuppressive drugs (Basiliximab, Rituximab, Thymoglobulin, ATG, ATGAM, IG iv, Plasmapheresis), maintenance immunosuppressive drugs (Cyclosporine A, Glucocorticoids, Tacrolimus, Mycophenolate mofetil, Everolimus, Azathioprine, Sirolimus, EC-MPA), infectious disease prophylaxis (e.g. TM-Sulfamethoxazole, Valaciclovir, Fluconazole, Atovaquone, Voriconazole, Quinolone), other drugs (e.g. Statins, beta-Blockers, oral antidiabetics).
The investigators will statistically illustrate the incidence, prevalence and type of skin neoplasms in the STCS. The investigators will show the association of the incidence of skin neoplasms and the exposure to different immunosuppressive drugs, other drugs and other parameters in the STCS (e.g. age, gender).
- Conditions
- Skin Cancer
- Medical subject headings
- Skin Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Skin Cancer in SOTRs
skin cancer event
Measured: 10 years
Incidence and type of skin neoplasms in STORs
skin neoplasm event
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJan 2008
- Primary completionDec 2017
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 4,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Günther Hofbauer, Prof MD, Principal investigator, University Hospital Zurich, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361229
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0276
- Acronym
- SCSTCS
- Status last verified
- Jul 2019
- First submitted
- 5 Feb 2015
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Share data with Swiss Transplant Cohort Study. Future projects can obtain data after project request is approved.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Cancer in Swiss Transplant Cohort Study
- ClinicalTrials.gov ID
- NCT02361229
- Acronym / sponsor ID
- SCSTCS / KEK-ZH-Nr. 2014-0276
- Conditions
- Skin Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Feb 2015 (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.
It's known that organ transplant recipients with long-term drug-induced immunosuppression have a increase of the life-time incidence of squamous cell carcinoma. This study will analyze the incidence and type of skin cancer in the Swiss Transplant Cohort Study and the association with exposure to immunosuppressive and antiinfective drugs and other parameters like age or gender of organ transplant recipients.
Detailed description
Organ transplant recipients with long-term drug-induced immunosuppression have an increase of the life-time incidence of squamous cell carcinoma and are also affected at an earlier age than the general population. In organ transplant recipients prognosis of squamous cell carcinoma differs due to more rapid growth, less differentiation and higher risk for metastases in comparison to the general population. Epidemiological data indicate that the risk of skin neoplasms in organ transplant recipients is related to the cumulative exposure to immunosuppressive drugs over time. It remains unclear wether this risk differs between drug classes.
This study is a prospective observational cohort study of kidney, heart, lung, liver, pancreas and small bowel transplant recipients enrolled into the Swiss Transplant Cohort Study (STCS).
Since 2008 almost all organ transplant recipients in Switzerland are enrolled to the STCS. The STCS collects
- baseline patient and case data: date of transplantation, age, gender, type of transplanted organ, past immunosuppression
- follow-up patient and case data: organ rejection with type and date of rejection, type of immunosuppression in response to organ rejection, graft loss with date of graft loss, immunosuppressive drug treatment, other drug treatment, death, drop out, occurrence of cancer and infections)
- drug exposure data (with start and stop dates): induction immunosuppressive drugs (Basiliximab, Rituximab, Thymoglobulin, ATG, ATGAM, IG iv, Plasmapheresis), maintenance immunosuppressive drugs (Cyclosporine A, Glucocorticoids, Tacrolimus, Mycophenolate mofetil, Everolimus, Azathioprine, Sirolimus, EC-MPA), infectious disease prophylaxis (e.g. TM-Sulfamethoxazole, Valaciclovir, Fluconazole, Atovaquone, Voriconazole, Quinolone), other drugs (e.g. Statins, beta-Blockers, oral antidiabetics).
The investigators will statistically illustrate the incidence, prevalence and type of skin neoplasms in the STCS. The investigators will show the association of the incidence of skin neoplasms and the exposure to different immunosuppressive drugs, other drugs and other parameters in the STCS (e.g. age, gender).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 1 hour and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Solid organ transplant recipients within the STCS.
Key inclusion criteria (4 listed)
- solid organ transplant recipients within the STCS
- patients with multiple organ transplantations will be included as well
- patients within the STCS, who gave the informed consent to use their data
- patients with graft loss will remain in the study, since they remain at risk of skin cancer development
Key exclusion criteria (1 listed)
- organ transplant recipients of non-solid organs (e.g. hematopoetic stem cell transplantation) within the STCS
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
Incidence of Skin Cancer in SOTRs
Time frame: 10 years
skin cancer event
Incidence and type of skin neoplasms in STORs
Time frame: 10 years
skin neoplasm event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: Yes. Share data with Swiss Transplant Cohort Study. Future projects can obtain data after project request is approved.
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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
University Hospital Zurich, Dermatology
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 Skin Cancer, 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 4 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: status not confirmed, as of the sponsor's last update on 29 Jul 2019. 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?
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?
Incidence of Skin Cancer in SOTRs (time frame: 10 years). The study lists 2 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 29 Jul 2019.