Squamous Cell CarcinomaNCT02095912
Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients
An observational study of Squamous Cell Carcinoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Squamous Cell Carcinoma
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to Jan 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Organ Transplant Recipients with: * > 9 Squamous Cell Carcinoma (SCC) in total or * > 2 SCC per year (in any one year) or * any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis
Who may be able to join
- Organ transplant recipients with:
- > 9 SCC in total or
- > 2 SCC per year (in any one year) or
- any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis
Who cannot join
- Non organ transplant recipients
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsspital Zürich
Zurich, Canton of Zurich, 8091
About this study
To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients.
Read the detailed description
Squamous Cell Carcinomas (SCC) are one of the most common skin cancers. They belong to the epithelial neoplasm of the skin, which manifest a local aggressive growth and have potential for metastasis. Organ transplant recipients have a hundredfold higher incidence of SCC.
Unfortunately the primary tumor, regional nodes, metastasis (TNM)-Classification for the prognosis of SCC in this group of patient has not yet been established. Therefore there are no standardised criteria for evaluation of local recurrence or prognosis.
The aim of this study is to identify criteria, which permit a risk assessment relating to aggressiveness of SCC.
- Conditions
- Squamous Cell Carcinoma
- Keywords
- Squamous Cell Carcinoma
- Medical subject headings
- Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of Squamous Cell Carcinoma
- Location
- exact size in mm
- histological classification (well-differentiated, moderately-differentiated, poorly differentiated, spindle cell morphology, desmoplastic, basi-squamous, acantholytic)
- Invasion
- rapid growth
- local recurrence
- sentinel node sampling
- Metastasis
Measured: 1 year
Secondary outcomes (1)
Sun exposure history
- skin type
- hair colour
- eye colour
- freckles
- cumulative UV exposure
Measurements will be assessed with questionnaire from about 150 participants.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guenther Hofbauer, Prof MD, Principal investigator, University Hospital Zurich, Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095912
- Sponsor's protocol ID
- KEK-ZH-2013-0591
- Status last verified
- Aug 2016
- First submitted
- 18 Feb 2014
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT02095912
- Acronym / sponsor ID
- KEK-ZH-2013-0591
- Conditions
- Squamous Cell Carcinoma
- Keywords
- Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Mar 2014 (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.
To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients.
Detailed description
Squamous Cell Carcinomas (SCC) are one of the most common skin cancers. They belong to the epithelial neoplasm of the skin, which manifest a local aggressive growth and have potential for metastasis. Organ transplant recipients have a hundredfold higher incidence of SCC.
Unfortunately the primary tumor, regional nodes, metastasis (TNM)-Classification for the prognosis of SCC in this group of patient has not yet been established. Therefore there are no standardised criteria for evaluation of local recurrence or prognosis.
The aim of this study is to identify criteria, which permit a risk assessment relating to aggressiveness of SCC.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Organ Transplant Recipients with: * > 9 Squamous Cell Carcinoma (SCC) in total or * > 2 SCC per year (in any one year) or * any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis
Key inclusion criteria (4 listed)
- > 9 SCC in total or
- > 2 SCC per year (in any one year) or
- any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis
Key exclusion criteria (1 listed)
- Non organ transplant recipients
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
Diameter of Squamous Cell Carcinoma
Time frame: 1 year
* Location * exact size in mm * histological classification (well-differentiated, moderately-differentiated, poorly differentiated, spindle cell morphology, desmoplastic, basi-squamous, acantholytic) * Invasion * rapid growth * local recurrence * sentinel node sampling * Metastasis
1 secondary outcome
Sun exposure history
Time frame: 1 year
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 10 Aug 2016.
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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.
Guenther Hofbauer, Prof MD principal investigator
University Hospital Zurich, Division of Dermatology
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 Squamous Cell Carcinoma, run by University of Zurich 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 4 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 10 Aug 2016. 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?
Diameter of Squamous Cell Carcinoma (time frame: 1 year). 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 10 Aug 2016.