Skin CancerNCT02395562
Viral Reactivation and Skin Cancer
An observational study of Skin Cancer and Infection Reactivation, run by University of Zurich at 1 site in Switzerland.
Trial summary
Several studies show that the incidence of skin cancer parallels the length and depth of immunosuppression. This study will analyze the correlation of viral reactivation and skin cancer in organ transplant recipients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Cancer, Infection Reactivation
- How many people
- 1,200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: organ transplant recipients within the STCS.
Who may be able to join
- oral and written consent to inclusion
- recipient of solid organ transplant
Who cannot join
- withdrawal of inform consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Dermatology
Zurich, Canton of Zurich, 8091
About this study
Official title: Association of Viral Reactivation and Skin Cancer in Organ Transplant Recipients
Several studies show that the incidence of skin cancer parallels the length and depth of immunosuppression. This study will analyze the correlation of viral reactivation and skin cancer in organ transplant recipients.
Read the detailed description
Squamous Cell Carcinoma of the skin (SCC) affects people in high numbers worldwide. While a yearly increase of over 2 million patients, who develop cancer, is recorded, organ transplant recipients (OTR) have a 60- to 100-fold higher risk of developing skin cancer. In OTRs, skin cancer is the most frequent tumor that appears, whereas 95% are nonmelanoma skin cancer cells: squamous cells or basal cell carcinomas. All OTRs need to be treated lifelong with immunosuppressants in order to prevent the rejection of the transplanted organ. However, this immunosuppressive treatment leads to a decrease of immunity, and therefore, cancer cells are able to proliferate easier.
Several studies show that the incidence of skin cancer parallels the length and depth of immunosuppression. The appearance of CD4 in OTRs with cutaneous carcinomas is significantly lower compared to those without skin lesions. Various findings have shown a positive correlation of the period of exposure to immunosuppressants and the risk of skin cancer. However, little is known about the dose or the type of drug is responsible for skin cancer. The uptake of three immunosuppressive medicaments compared to the uptake of two results in a 3-fold increased risk of developing cancer. The consequence of the immunosuppressive therapy is reversible; patients who stop immunosuppressive treatment often show a decrease in skin cancer. The highest risk for organ rejection is during the first three months after transplantation. Therefore, an increased dose of immunosuppressors is used during this time.
In addition to cancer, a high increase of viral infections and reactivations is seen in OTRs. Over 90% of the population carries herpesviruses. The risk of viral infection and reactivation is much higher in OTRs. While inducing a decrease in immunosurveillance, herpesvirus can spread easier.
Herpesvirus infections due to the eight human herpes viruses (HHV) are more frequent by immunosuppression in OTRs. Once a patient is infected with one of the human herpesvirus types (Herpes simplex viruses 1 and 2, varicella-zoster virus, Epstein-Barr virus, human cytomegalovirus, human herpesvirus 6 and 7, or Kaposi's sarcoma-associated herpesvirus), the virus is able to establish a latent, non-productive infection and maintains the capacity for a life-long reactivation. Due to the decrease of immunity, OTRs are highly susceptible to activate this latent herpesviral infection, which is a critical aspect of the immunosuppressive treatment. The risk of the reactivation of Cytomegalovirus and Epstein-Barr virus in OTRs is much higher compared to the general population.
Taking the above discussed findings together, the investigators hypothesize that viral infections and reactivations correlate positively with skin cancer in OTRs. Furthermore, the investigators think that viral reactivation and infection can be used as a marker for a later incidence of skin cancer. While virus infections and reactivations appear early, OTRs become affected by SCC in the early and in the late period after the transplantation. The investigators thus aim to analyze existing data from the STCS and its nested studies to test these hypotheses: To assess the correlation of viral replication and skin cancer in organ transplant recipients and to assess viral replication as predictor for skin cancer. The investigators are interested in all data available from other studies of the STCS and to divide all organ transplant recipients e.g. for CMV in four groups: no replication, a larger group who show asymptomatic viral replication, some of them with viral syndrome and the ones with proven disease.
- Conditions
- Skin Cancer, Infection Reactivation
- Medical subject headings
- Skin Neoplasms, Latent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OTR and viral reactivation | Organ transplant recipients with and without viral reactivation and skin cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of skin cancer with viral reactivation in organ transplant recipients
Measured: 10 years
Secondary outcomes (1)
The association of viral reactivation and infection in the first year and skin cancer in the following years. Can one be used as a marker for the other one?
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 posted23 Mar 2015 (estimated)
- Study startJan 2008
- Primary completionJan 2016
- Study completionJun 2016
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
- Retrospective
- Enrolment
- 1,200 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, University Hospital Zurich, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395562
- Sponsor's protocol ID
- FUP063
- Status last verified
- Jul 2016
- First submitted
- 17 Mar 2015
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: shared with Swiss Transplant Cohort Study. Future projects can obtain data after having a project request approved.
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
- Association of Viral Reactivation and Skin Cancer in Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT02395562
- Acronym / sponsor ID
- FUP063
- Conditions
- Skin Cancer, Infection Reactivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Mar 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.
Several studies show that the incidence of skin cancer parallels the length and depth of immunosuppression. This study will analyze the correlation of viral reactivation and skin cancer in organ transplant recipients.
Detailed description
Squamous Cell Carcinoma of the skin (SCC) affects people in high numbers worldwide. While a yearly increase of over 2 million patients, who develop cancer, is recorded, organ transplant recipients (OTR) have a 60- to 100-fold higher risk of developing skin cancer. In OTRs, skin cancer is the most frequent tumor that appears, whereas 95% are nonmelanoma skin cancer cells: squamous cells or basal cell carcinomas. All OTRs need to be treated lifelong with immunosuppressants in order to prevent the rejection of the transplanted organ. However, this immunosuppressive treatment leads to a decrease of immunity, and therefore, cancer cells are able to proliferate easier.
Several studies show that the incidence of skin cancer parallels the length and depth of immunosuppression. The appearance of CD4 in OTRs with cutaneous carcinomas is significantly lower compared to those without skin lesions. Various findings have shown a positive correlation of the period of exposure to immunosuppressants and the risk of skin cancer. However, little is known about the dose or the type of drug is responsible for skin cancer. The uptake of three immunosuppressive medicaments compared to the uptake of two results in a 3-fold increased risk of developing cancer. The consequence of the immunosuppressive therapy is reversible; patients who stop immunosuppressive treatment often show a decrease in skin cancer. The highest risk for organ rejection is during the first three months after transplantation. Therefore, an increased dose of immunosuppressors is used during this time.
In addition to cancer, a high increase of viral infections and reactivations is seen in OTRs. Over 90% of the population carries herpesviruses. The risk of viral infection and reactivation is much higher in OTRs. While inducing a decrease in immunosurveillance, herpesvirus can spread easier.
Herpesvirus infections due to the eight human herpes viruses (HHV) are more frequent by immunosuppression in OTRs. Once a patient is infected with one of the human herpesvirus types (Herpes simplex viruses 1 and 2, varicella-zoster virus, Epstein-Barr virus, human cytomegalovirus, human herpesvirus 6 and 7, or Kaposi's sarcoma-associated herpesvirus), the virus is able to establish a latent, non-productive infection and maintains the capacity for a life-long reactivation. Due to the decrease of immunity, OTRs are highly susceptible to activate this latent herpesviral infection, which is a critical aspect of the immunosuppressive treatment. The risk of the reactivation of Cytomegalovirus and Epstein-Barr virus in OTRs is much higher compared to the general population.
Taking the above discussed findings together, the investigators hypothesize that viral infections and reactivations correlate positively with skin cancer in OTRs. Furthermore, the investigators think that viral reactivation and infection can be used as a marker for a later incidence of skin cancer. While virus infections and reactivations appear early, OTRs become affected by SCC in the early and in the late period after the transplantation. The investigators thus aim to analyze existing data from the STCS and its nested studies to test these hypotheses: To assess the correlation of viral replication and skin cancer in organ transplant recipients and to assess viral replication as predictor for skin cancer. The investigators are interested in all data available from other studies of the STCS and to divide all organ transplant recipients e.g. for CMV in four groups: no replication, a larger group who show asymptomatic viral replication, some of them with viral syndrome and the ones with proven disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTR and viral reactivation | – | –Organ transplant recipients with and without viral reactivation and skin cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- organ transplant recipients within the STCS.
Key inclusion criteria (2 listed)
- oral and written consent to inclusion
- recipient of solid organ transplant
Key exclusion criteria (1 listed)
- withdrawal of inform consent
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
The correlation of skin cancer with viral reactivation in organ transplant recipients
Time frame: 10 years
1 secondary outcome
The association of viral reactivation and infection in the first year and skin cancer in the following years. Can one be used as a marker for the other one?
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Individual participant dataSharing planned: Yes. shared with Swiss Transplant Cohort Study. Future projects can obtain data after having a project request 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 and Infection Reactivation, 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 2 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The correlation of skin cancer with viral reactivation in organ transplant recipients (time frame: 10 years). 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.