NCT02395562

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

8 years

First QC Date

March 17, 2015

Last Update Submit

July 11, 2016

Conditions

Skin CancerInfection Reactivation

Outcome Measures

Primary Outcomes (1)

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

    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?

    10 years

Study Arms (1)

OTR and viral reactivation

Organ transplant recipients with and without viral reactivation and skin cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

organ transplant recipients within the STCS.

You may qualify if:

  • recipient of solid organ transplant

You may not qualify if:

  • withdrawal of inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Skin NeoplasmsLatent Infection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesInfections

Study Officials

  • Günther Hofbauer, Prof. MD

    University Hospital Zurich, Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 23, 2015

Study Start

January 1, 2008

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

July 13, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

shared with Swiss Transplant Cohort Study. Future projects can obtain data after having a project request approved.

Locations

CH(1)