NeoplasmsNCT02491580
Post-transplant Cancer Incidence and Survival in Patients With or Without Pre-transplant Cancer
An observational study of Neoplasms and Kidney Failure, run by Uppsala University at 1 site in Sweden.
Trial summary
Patients with previous malignancies have increasingly been accepted for renal transplantation. However, post-transplant malignancy risk and survival rates of these patients are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Kidney Failure
- How many people
- 2,370 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2014to Jun 2015
- 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: Kidney transplanted patients in Uppsala or Europe with or without a pre-transplant cancer.
Who may be able to join
- Kidney transplanted patients from January 1982 through December 2013 with or without a pre transplant cancer.
Who cannot join
- Simultaneous kidney+pancreas transplantation.
- Islet cell transplanted patients
- Undiagnosed malignancies at the time of transplantation
- Death within a week after transplantation
- First transplantation at another hospital
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Uppsala University, Department of Surgical Sciences, Section of Transplantation Surgery
Uppsala, SE-751 85
About this study
Patients with previous malignancies have increasingly been accepted for renal transplantation. However, post-transplant malignancy risk and survival rates of these patients are unknown. Our aim was to assess if previous malignancies pose an unnecessarily high risk of post-transplant malignant tumours and if the organs as a resource are too limited for investment in this patient group.
- Conditions
- Neoplasms, Kidney Failure
- Medical subject headings
- Neoplasms, Renal Insufficiency
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 |
|---|---|---|
| KTx Uppsala | Patients who have received a kidney transplant in Uppsala. | |
| KTx Europe | Patients who have received a kidney transplant in Uppsala. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-transplant cancer
Measured: Up to 33 years starting in January 1982.
Secondary outcomes (2)
Patient survival
Measured: Up to 33 years starting in January 1982.
Cancer-induced mortality
Measured: Up to 33 years starting in January 1982.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 2,370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivan Hellström, MD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491580
- Sponsor's protocol ID
- PreTXCa
- Status last verified
- Jul 2015
- First submitted
- 30 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hellstrom V, Lorant T, Dohler B, Tufveson G, Enblad G. High Posttransplant Cancer Incidence in Renal Transplanted Patients With Pretransplant Cancer. Transplantation. 2017 Jun;101(6):1295-1302. doi: 10.1097/TP.0000000000001225.
PubMed 27163539
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-transplant Cancer Incidence and Survival in Patients With or Without Pre-transplant Cancer
- ClinicalTrials.gov ID
- NCT02491580
- Acronym / sponsor ID
- PreTXCa
- Conditions
- Neoplasms, Kidney Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,370 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Jul 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.
Patients with previous malignancies have increasingly been accepted for renal transplantation. However, post-transplant malignancy risk and survival rates of these patients are unknown. Our aim was to assess if previous malignancies pose an unnecessarily high risk of post-transplant malignant tumours and if the organs as a resource are too limited for investment in this patient group.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KTx Uppsala | – | –Patients who have received a kidney transplant in Uppsala. |
| KTx Europe | – | –Patients who have received a kidney transplant in Uppsala. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplanted patients in Uppsala or Europe with or without a pre-transplant cancer.
Key inclusion criteria (1 listed)
- Kidney transplanted patients from January 1982 through December 2013 with or without a pre transplant cancer.
Key exclusion criteria (5 listed)
- Simultaneous kidney+pancreas transplantation.
- Islet cell transplanted patients
- Undiagnosed malignancies at the time of transplantation
- Death within a week after transplantation
- First transplantation at another hospital
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
Incidence of post-transplant cancer
Time frame: Up to 33 years starting in January 1982.
2 secondary outcomes
Patient survival
Time frame: Up to 33 years starting in January 1982.
Cancer-induced mortality
Time frame: Up to 33 years starting in January 1982.
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 8 Jul 2015.
- Derived from this study: PubMed 27163539Hellstrom V, Lorant T, Dohler B, Tufveson G, Enblad G. High Posttransplant Cancer Incidence in Renal Transplanted Patients With Pretransplant Cancer. Transplantation. 2017 Jun;101(6):1295-1302. doi: 10.1097/TP.0000000000001225.
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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.
Vivan Hellström, MD principal investigator
Uppsala University
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 Neoplasms and Kidney Failure, run by Uppsala University at 1 site in Sweden.
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 5 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 8 Jul 2015. 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 Sweden. 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?
Incidence of post-transplant cancer (time frame: Up to 33 years starting in January 1982.). 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 NCT02491580, 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 8 Jul 2015.