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CompletedNCT02395562Updated Jul 13, 2016

Viral Reactivation and Skin Cancer

An observational study in Skin Cancer and Infection Reactivation, sponsored by University of Zurich. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by University of Zurich · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,200
Sex
All
01

Study 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 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.

02

Conditions studied

  • Skin Cancer
  • Infection Reactivation

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03

In context

Skin Neoplasms

582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.

This study's enrollment of 1,200 is above the median of 200 across 134 observational studies indexed under Skin Neoplasms.

Browse Skin Neoplasms studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

organ transplant recipients within the STCS.

Inclusion criteria

  • oral and written consent to inclusion
  • recipient of solid organ transplant

Exclusion criteria

Exclusion Criteria:

  • withdrawal of inform consent
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,200 participants (actual)
Patient registry
No

Groups and cohorts

  • OTR and viral reactivation

    Organ transplant recipients with and without viral reactivation and skin cancer

06

What researchers measure

Primary outcomes

  1. The correlation of skin cancer with viral reactivation in organ transplant recipients

    Time frame: 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?

    Time frame: 10 years

07

Study locations

1 site
  • University Hospital Zurich, Dermatology
    Zurich, 8091, Switzerland
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References and documents

Individual participant data

Plan to share: Yes — shared with Swiss Transplant Cohort Study. Future projects can obtain data after having a project request approved.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02395562
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Mar 23, 2015
Start date
Jan 2008
Primary completion
Jan 2016
Completion
Jun 2016
Last update
Jul 13, 2016

Study contacts

Günther Hofbauer, Prof. MD
principal investigator · University Hospital Zurich, Dermatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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