Squamous Cell CarcinomaNCT01976468
Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The "SCOPE-ITSCC Metastases Study"
An observational study of Squamous Cell Carcinoma, run by University of Zurich at 2 sites in 2 countries.
Trial summary
The investigators hypothesize that a low number of SCC in OTR will metastasize. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- SCC metastasis
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2013to Jan 2025
- 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: organ transplant recipients
Who may be able to join
- Organ-transplant recipients (OTR).
- Histologically proven cutaneous invasive SCC at time of inclusion
Who cannot join
- Lack of consent.
- History of metastases of cutaneous SCC
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
University Hospital Zurich, Division of Dermatology
Zurich, Canton of Zurich, 8091
About this study
The investigators hypothesize that a low number of SCC in OTR will metastasize.
Read the detailed description
In a large international multicenter prospective observational study a total number of 1000 OTR (organ transplant recipients) with a histologically proven cutaneous SCC (squamous cell carcinoma) will be included in 10 centers and followed during 2 years to establish the cumulative incidence of metastases in OTR with cutaneous SCC.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- SCC metastasis
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCC metastasisOther
occurrence of SCC metastasis
| Study group | Role | What they receive |
|---|---|---|
| SCC metastasis | organ transplant recipients Receives: Other: SCC metastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCC metastasis detection
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2023 (estimated)
- Study completionJan 2025 (estimated)
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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Günther Hofbauer, Prof MD, Principal investigator, University Hospital Zurich, Division of DermatologyJan Nico Bouwes Bavinck, Study chair, Leiden University Medical CenterRoel Genders, MD, Study director, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976468
- Sponsor's protocol ID
- SCOPE-ITSCC metastases
- Status last verified
- Jul 2019
- First submitted
- 29 Oct 2013
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The "SCOPE-ITSCC Metastases Study"
- ClinicalTrials.gov ID
- NCT01976468
- Acronym / sponsor ID
- SCOPE-ITSCC metastases
- Conditions
- Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- Nov 2013 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 5 Nov 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.
The investigators hypothesize that a low number of SCC in OTR will metastasize.
Detailed description
In a large international multicenter prospective observational study a total number of 1000 OTR (organ transplant recipients) with a histologically proven cutaneous SCC (squamous cell carcinoma) will be included in 10 centers and followed during 2 years to establish the cumulative incidence of metastases in OTR with cutaneous SCC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCC metastasis | – | Other: SCC metastasisorgan transplant recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- organ transplant recipients
Key inclusion criteria (2 listed)
- Organ-transplant recipients (OTR).
- Histologically proven cutaneous invasive SCC at time of inclusion
Key exclusion criteria (2 listed)
- Lack of consent.
- History of metastases of cutaneous SCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCC metastasisoccurrence of SCC metastasis | Other | SCC metastasis |
Primary outcome
SCC metastasis detection
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
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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.
Günther Hofbauer, Prof MD principal investigator
University Hospital Zurich, Division of Dermatology
Jan Nico Bouwes Bavinck study chair
Leiden University Medical Center
Roel Genders, MD study director
Leiden University Medical Center
2 sites in 2 countries: 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 2 sites in 2 countries.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, 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?
Results are not available in the source record.
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?
SCC metastasis detection (time frame: two 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 29 Jul 2019.