EVER(Epidermodysplasia Verruciformis Levandowsky-Lutz)/TMC(TransMembral Channel Like Protein) Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
Andreas Arnold, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01942005
First received: August 7, 2013
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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

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


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 ]

Estimated Enrollment: 377
Study Start Date: January 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942005

Contacts
Contact: Andreas Arnold, MD +41 61 328 67 69 andreas.arnold@usb.ch

Locations
Switzerland
University Hospital Basel, Dermatology Recruiting
Basel, Basel Stadt, Switzerland, 4031
Contact: Andreas Arnold, MD    +41 61 328 67 69    andreas.arnold@usb.ch   
Principal Investigator: Andreas Arnold, MD         
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: September 9, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Epidermodysplasia Verruciformis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014