ImmunosuppressionEBVER/TMCNCT01942005
EVER/TMC Mutation as Marker of the Risk of Cutaneous Carcinoma in Immunosuppressed Patients
An observational study of Immunosuppression and Neoplasm, run by Andreas Arnold at 1 site in Switzerland.
Trial summary
Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunosuppression, Neoplasm
- How many people
- 144 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent organ transplatation or patients who have a HIV infection
Who may be able to join
- patients in an immunosuppressive condition either by immunosuppressants or by HIV infection
Who cannot join
- written informed consent not given
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Dermatology
Basel, Canton of Basel-City, 4031
About this study
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
Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.
Read the 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.
- Conditions
- Immunosuppression, Neoplasm
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.
Measured: 7 years
Secondary outcomes (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.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startJan 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andreas Arnold
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andreas Arnold, University Hospital, Basel, Switzerland
- Investigators
- Andreas Arnold, MD, Principal investigator, University Hospital Basel, Dermatology, CH-4031 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942005
- Sponsor's protocol ID
- 11/10
- Acronym
- EBVER/TMC
- Status last verified
- Dec 2014
- First submitted
- 7 Aug 2013
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01942005
- Acronym / sponsor ID
- EBVER/TMC / 11/10
- Conditions
- Immunosuppression, Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Andreas ArnoldUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent organ transplatation or patients who have a HIV infection
Key inclusion criteria (1 listed)
- patients in an immunosuppressive condition either by immunosuppressants or by HIV infection
Key exclusion criteria (1 listed)
- written informed consent not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen.
Time frame: 7 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Arnold, MD principal investigator
University Hospital Basel, Dermatology, CH-4031 Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression and Neoplasm, run by Andreas Arnold at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of mutation / specific polymorphism of the EVER/TMC6 and/or EVER/TMC8 gen. (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.