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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01942005

First Posted: September 13, 2013

Last Update Posted: December 4, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Andreas Arnold, University Hospital, Basel, Switzerland

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 Andreas Arnold, 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 ]

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 ]

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

Information from the National Library of Medicine

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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

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


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 Submitted:	August 7, 2013
First Posted:	September 13, 2013
Last Update Posted:	December 4, 2014
Last Verified:	December 2014

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