NeoplasmsMALTXNCT02241564
Malignancies in Transplanted Patients
An observational study of Neoplasms, run by Uppsala University at 1 site in Sweden.
Trial summary
The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection and Switch from calcineurin inhibitor to an mTOR inhibitor
- How many people
- 95 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2007to Jun 2017
- 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, pancreas or liver transplanted patients in the Uppsala/Örebro region with a diagnosed malignancy pre or post transplantation
Who may be able to join
- Patients willing and capable of giving written informed consent of participation in the project
- Patients with a previous diagnosed or presently diagnosed or reoccurrence of a malignancy (other then basal cell carcinoma)
Who cannot join
- Patients with a primary liver cancer as cause of the transplantation
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery, Section of Transplantation Surgery, Uppsala University Hospital
Uppsala, SE-75185
About this study
Official title: Follow-up of Malignancies in Transplanted Patients
The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the program.
- Conditions
- Neoplasms
- Being tested
- Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection, Switch from calcineurin inhibitor to an mTOR inhibitor
- Keywords
- Immunosuppression
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detectionOther
Switch from calcineurin inhibitor to an mTOR inhibitorDrug
| Study group | Role | What they receive |
|---|---|---|
| Malignancy post transplantation | Not described Receives: Other: Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection; Drug: Switch from calcineurin inhibitor to an mTOR inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
After inclusion
Measured: 12 months, 2 years, 3 years
Secondary outcomes (5)
Graft survival
After inclusion
Measured: 12 months, 2 years, 3 years
ImmuKnow Assay value
Measured: 12 months
Tumour progression/regression/reoccurrence
Measured: 12 months, 2 years, 3 years
Maintained switch of immunosuppression from calcineurin inhibitor to mTOR inhibitor
Measured: 3 years
Kidney function
Creatinine measure
Measured: 12 months, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startNov 2007
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Lorant, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241564
- Sponsor's protocol ID
- MALTX-001
- Acronym
- MALTX
- Status last verified
- Oct 2017
- First submitted
- 11 Sep 2014
- Last updated
- 26 Oct 2017
- 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 27163539Hellstrom VC, Enstrom Y, von Zur-Muhlen B, Hagberg H, Laurell A, Nyberg F, Backman L, Opelz G, Dohler B, Holmberg L, Tufveson G, Enblad G, Lorant T. Malignancies in transplanted patients: Multidisciplinary evaluation and switch to mTOR inhibitors after kidney transplantation - experiences from a prospective, clinical, observational study. Acta Oncol. 2016 Jun;55(6):774-81. doi: 10.3109/0284186X.2015.1130855. Epub 2016 Jan 29.
PubMed 26824275
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Malignancies in Transplanted Patients
- ClinicalTrials.gov ID
- NCT02241564
- Acronym / sponsor ID
- MALTX / MALTX-001
- Conditions
- Neoplasms
- Keywords
- Immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Sep 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.
The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the program.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malignancy post transplantation | – | Other: Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection, Drug: Switch from calcineurin inhibitor to an mTOR inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney, pancreas or liver transplanted patients in the Uppsala/Örebro region with a diagnosed malignancy pre or post transplantation
Key inclusion criteria (2 listed)
- Patients willing and capable of giving written informed consent of participation in the project
- Patients with a previous diagnosed or presently diagnosed or reoccurrence of a malignancy (other then basal cell carcinoma)
Key exclusion criteria (1 listed)
- Patients with a primary liver cancer as cause of the transplantation
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 |
|---|---|---|
| Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection | Other | Malignancy post transplantation |
| Switch from calcineurin inhibitor to an mTOR inhibitor | Drug | Malignancy post transplantation |
Primary outcome
Patient survival
Time frame: 12 months, 2 years, 3 years
After inclusion
5 secondary outcomes
Graft survival
Time frame: 12 months, 2 years, 3 years
ImmuKnow Assay value
Time frame: 12 months
Tumour progression/regression/reoccurrence
Time frame: 12 months, 2 years, 3 years
Maintained switch of immunosuppression from calcineurin inhibitor to mTOR inhibitor
Time frame: 3 years
Kidney function
Time frame: 12 months, 2 years, 3 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 26 Oct 2017.
- Background: 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.
- Derived from this study: PubMed 26824275Hellstrom VC, Enstrom Y, von Zur-Muhlen B, Hagberg H, Laurell A, Nyberg F, Backman L, Opelz G, Dohler B, Holmberg L, Tufveson G, Enblad G, Lorant T. Malignancies in transplanted patients: Multidisciplinary evaluation and switch to mTOR inhibitors after kidney transplantation - experiences from a prospective, clinical, observational study. Acta Oncol. 2016 Jun;55(6):774-81. doi: 10.3109/0284186X.2015.1130855. Epub 2016 Jan 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 2 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 26 Oct 2017. 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?
Patient survival (time frame: 12 months, 2 years, 3 years). 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 NCT02241564, which also lists 2 linked publications.
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 26 Oct 2017.