EVER/TMC Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients (EBVER/TMC)
This study has been completed.
Sponsor:
Andreas Arnold
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
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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 |
Resource links provided by NLM:
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) |
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
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 February 26, 2015