EVER/TMC Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients (EBVER/TMC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreas Arnold, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01942005
First received: August 7, 2013
Last updated: December 3, 2014
Last verified: December 2014
  Purpose

Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.


Condition
Immunosuppression
Neoplasm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EVER/TMC Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients,Especially Patients After Organ Transplantation and Patients With HIV Infection

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correlation between possibly detected mutation/specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen and a composite of kind and number of neoplasm, age of patients, UV burden, duration and kind of immunosuppression. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blutsample


Enrollment: 144
Study Start Date: January 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Detailed Description:

correlation between possibly detected mutation/specific polymorphism and kind and number of neoplasm, age of patients, UV burden, duration and kind of immunosuppression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients who underwent organ transplatation or patients who have a HIV infection

Criteria

Inclusion Criteria:

  • patients in an immunosuppressive condition either by immunosuppressants or by HIV infection

Exclusion Criteria:

  • written informed consent not given
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01942005

Locations
Switzerland
University Hospital Basel, Dermatology
Basel, Basel Stadt, Switzerland, 4031
Sponsors and Collaborators
Andreas Arnold
Investigators
Principal Investigator: Andreas Arnold, MD University Hospital Basel, Dermatology, CH-4031 Basel
  More Information

No publications provided

Responsible Party: Andreas Arnold, Dr. med. Andreas Arnold, senior physician, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01942005     History of Changes
Other Study ID Numbers: 11/10
Study First Received: August 7, 2013
Last Updated: December 3, 2014
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on July 30, 2015