NCT02361229

Brief 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 antiinfective drugs and other parameters like age or gender of organ transplant recipients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

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
unknown

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
7.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

9.9 years

First QC Date

February 5, 2015

Last Update Submit

July 25, 2019

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of Skin Cancer in SOTRs

    skin cancer event

    10 years

  • Incidence and type of skin neoplasms in STORs

    skin neoplasm event

    10 years

Eligibility Criteria

Age1 Hour+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Solid organ transplant recipients within the STCS.

You may qualify if:

  • 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

You may not qualify if:

  • organ transplant recipients of non-solid organs (e.g. hematopoetic stem cell transplantation) within the STCS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Dermatology

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Günther Hofbauer, Prof MD

    University Hospital Zurich, Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 11, 2015

Study Start

January 1, 2008

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

July 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Share data with Swiss Transplant Cohort Study. Future projects can obtain data after project request is approved.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
2019-2080
Access Criteria
STCS scientific committee approval and ethical committee approval (IRB)

Locations

CH(1)