Heart CancerNCT02333279
Cancer Development In Organ Transplant Recipients
An observational study of Heart Cancer and Kidney Cancer, run by University of Zurich at 1 site in Switzerland.
Trial summary
The investigators will determine the cancer risk in organ transplant recipients compared to the general population with the help of statistical analysis. Secondly the investigators will try to characterize the different cancer types. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Cancer, Kidney Cancer, Lung Cancer
- How many people
- 1,800 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2008to Jul 2019
- How long will I take part?
- 5 Years
- 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: All solid organ transplant recipients in Switzerland since 2008 who have given their consent to be included in the study.
Who may be able to join
- We will select all patients within the STCS based on the date of the first solid organ transplantation. Patients with multiple organ transplantations will be included as well. Patients contribute to the study observation time until death or end of follow-up due to other reasons.
Who cannot join
- We will exclude patients with non-solid organ transplantation (e.g. hematopoietic stem cell transplantation), because the detailing of information in the STCS is insufficient to allow for detailed analysis of cancer development and control of relevant confounders. We will exclude
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Dermatology
Zurich, 8091
About this study
The investigators will determine the cancer risk in organ transplant recipients compared to the general population with the help of statistical analysis. Secondly the investigators will try to characterize the different cancer types.
Read the detailed description
This cohort analyses will focus on incident and recurrent cases of development of non-skin cancer over time. We will consider time to first formation of non-skin solid cancer after solid organ transplantation as well as the cumulative number of non-skin solid cancer formation over time. Both aspects are equally important and will be reflected in the analytic methods of this study. Theses analyses will be restricted to the most prevalent transplantation types of heart, kidney, liver, and lung.
- Conditions
- Heart Cancer, Kidney Cancer, Lung Cancer, Pancreas Cancer, Liver Cancer
- Medical subject headings
- Heart Neoplasms, Kidney Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Organ transplant recipients | Follow-ups in regular intervals following the organ transplant date. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of solid cancers
Number of solid cancers
Measured: Ten Year followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startMay 2008
- Primary completionMay 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Insel Gruppe AG, University Hospital Bern, Cantonal Hospital of St. Gallen, University Hospital, Geneva, University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Gunther FL Hofbauer, MD, Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333279
- Sponsor's protocol ID
- FUP062
- Other IDs
- snctp000000587
- Status last verified
- Jul 2019
- First submitted
- 18 Dec 2014
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lengwiler E, Stampf S, Zippelius A, Salati E, Zaman K, Schafer N, Schardt J, Siano M, Hofbauer G, The Swiss Transplant Cohort Study. Solid cancer development in solid organ transplant recipients within the Swiss Transplant Cohort Study. Swiss Med Wkly. 2019 May 19;149:w20078. doi: 10.4414/smw.2019.20078. eCollection 2019 May 6.
PubMed 31104307
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
- Cancer Development In Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT02333279
- Acronym / sponsor ID
- FUP062
- Conditions
- Heart Cancer, Kidney Cancer, Lung Cancer, Pancreas Cancer, Liver Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Insel Gruppe AG, University Hospital Bern, Cantonal Hospital of St. Gallen, University Hospital, Geneva, University of Lausanne Hospitals
- Study start
- May 2008 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Jan 2015 (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 will determine the cancer risk in organ transplant recipients compared to the general population with the help of statistical analysis. Secondly the investigators will try to characterize the different cancer types.
Detailed description
This cohort analyses will focus on incident and recurrent cases of development of non-skin cancer over time. We will consider time to first formation of non-skin solid cancer after solid organ transplantation as well as the cumulative number of non-skin solid cancer formation over time. Both aspects are equally important and will be reflected in the analytic methods of this study. Theses analyses will be restricted to the most prevalent transplantation types of heart, kidney, liver, and lung.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Organ transplant recipients | – | –Follow-ups in regular intervals following the organ transplant date. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All solid organ transplant recipients in Switzerland since 2008 who have given their consent to be included in the study.
Key inclusion criteria (1 listed)
- We will select all patients within the STCS based on the date of the first solid organ transplantation. Patients with multiple organ transplantations will be included as well. Patients contribute to the study observation time until death or end of follow-up due to other reasons.
Key exclusion criteria (1 listed)
- We will exclude patients with non-solid organ transplantation (e.g. hematopoietic stem cell transplantation), because the detailing of information in the STCS is insufficient to allow for detailed analysis of cancer development and control of relevant confounders. We will exclude
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
Number of solid cancers
Time frame: Ten Year followup
Number of solid cancers
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 29 Jul 2019.
- Results publication: PubMed 31104307Lengwiler E, Stampf S, Zippelius A, Salati E, Zaman K, Schafer N, Schardt J, Siano M, Hofbauer G, The Swiss Transplant Cohort Study. Solid cancer development in solid organ transplant recipients within the Swiss Transplant Cohort Study. Swiss Med Wkly. 2019 May 19;149:w20078. doi: 10.4414/smw.2019.20078. eCollection 2019 May 6.
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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.
Gunther FL Hofbauer, MD principal investigator
University Hospital, Zürich
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 Heart Cancer and Kidney Cancer, 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 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 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 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?
Number of solid cancers (time frame: Ten Year followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02333279, which also lists 1 linked publication.
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.