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

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ClinicalTrials.gov Identifier: NCT01942005
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Andreas Arnold, University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.

Condition or disease
Immunosuppression Neoplasm

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.

Study Design
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Study Type : Observational
Actual Enrollment : 144 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen. [ Time Frame: 7 years ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Blutsample

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014