PheochromocytomaMUPPETNCT03344016
Multicenter Pheochromocytoma and Paraganglioma Evaluation
A study testing Contact by clinical center in people with Pheochromocytoma and Paraganglioma, run by Felix Beuschlein at 1 site in Switzerland.
Trial summary
Target population: Patients with (1) newly diagnosed or (2) past history of pheochromocytomas and paragangliomas (PPGL) or (3) carrier of genetic mutations in known PPGL susceptibility genes. International multicenter prospective cohort study with randomized intervention (special care follow-up vs. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Pheochromocytoma, Paraganglioma
- What is being tested?
- Contact by clinical center
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,148 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2017to 1 Nov 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- male and female patients (≥ 5 years of age), who fulfill one or more of the following criteria: (i) Patients with a newly diagnosed PPGL. (ii) Patients with a previous history of PPGLs. (iii) Carrier of genetic mutations known to predispose for the development of PPGLs.
- All subjects must have read, understood and signed the informed consent form, before inclusion into the study protocol. Signed parental consent must be obtained for children with suspected PPGLs who are enrolled in the study.
Who cannot join
- Patients with impaired mental capacity that precludes informed consent.
- Pregnancy does not constitute criteria for exclusion from the protocol. However, in pregnant women no Clonidine testing, no PET scanning, MIBG scanning or contrast CT will be performed.
- Patients at risk from injury from the MRI magnet due to implantable metal or who suffer from anxiety in enclosed spaces are excluded from MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Felix Beuschlein, M.D., +41 44 255 36 25, felix.beuschlein@usz.ch
Martin Reincke, M.D., +49 89 4400 52100, martin.reincke@med.uni-muenchen.de
About this study
Official title: The MUPPET-study: Multicenter Pheochromocytoma and Paraganglioma Evaluation for Follow-up Screening, Genetics Sub-Typing, Therapy and Outcome
Target population:
Patients with (1) newly diagnosed or (2) past history of pheochromocytomas and paragangliomas (PPGL) or (3) carrier of genetic mutations in known PPGL susceptibility genes.
Read more
International multicenter prospective cohort study with randomized intervention (special care follow-up vs. standard care follow-up).
All patients will receive instructions about follow-up at the time point of study inclusion. Patients randomized to the standard care follow-up group will be advised to return annually for follow-up according to current routine practice (without active re-scheduling). In contrast, patients randomized to the special care follow-up group will also be advised to return annually for follow-up but these patients will be actively invited, re-scheduled and reminded by the centers to meet scheduled follow-up appointments.
Read the detailed description
The long-term goal of the research planned under this protocol is to reduce morbidity and mortality of patients with PPGLs by improving approaches for management, follow-up and therapy of affected patients. As a first step towards attaining this goal, the primary objective of this protocol is to investigate whether standardized follow-up results in improved long-term outcome in terms of less morbidity and mortality as compared. The central hypothesis is that pro-active, structured and periodic disease screening and management of patients at risk for developing PPGLs and other neoplasms can lead to earlier detection of tumors and reduce adverse outcomes associated with cardiovascular, metabolic and oncologic complications of the tumors than standard care follow-up. The underlying rationale is that establishing improved outcomes for patients at risk for PPGLs will enable evidence-based recommendations for disease follow-up and management, thereby establishing wider acceptance and use of outlined practices with ensuing improvements in the health and quality of life of affected patients and their families.
In addition to the primary objective directed at establishing whether standardized and structured follow-up of patients with an increased risk for new events of PPGL (recurrent tumor, new tumor, or metastases) will result in improved longterm outcome, this protocol will enable several secondary objectives to be addressed using clinical (e.g. age, mode of presentation), biochemical, metabolic and genetic characteristics. These include:
- to identify prognostic markers of disease progression
- to assess whether clinical presentation, cardiovascular, metabolic and biochemical phenotype, genetic background and tumor characteristics (location, size, recurrence, pathology) are useful for development of personalized follow-up strategies.
- to investigate whether standardized follow-up affects quality of life
- Conditions
- Pheochromocytoma, Paraganglioma
- Being tested
- Contact by clinical center
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact by clinical centerOther
Patients will be acitvely contacted by the clinical center for follow-up procedure
| Study group | Role | What they receive |
|---|---|---|
| Standard care follow-up group | No intervention | Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines. |
| Special care follow-up group | Active comparator | In addition to the information leaflet patients will be actively contacted by the clinical center to increase the likelihood that patients meet recommended follow-up schedules. Receives: Other: Contact by clinical center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
to investigate whether standardized follow-up for patients at risk for PPGL improves long-term outcome
Measured: 18 years
Secondary outcomes (12)
Time to recurrence
Time to recurrence
Measured: 18 years
Size of recurrent tumors
Size of recurrent tumors
Measured: 18 years
Numbers of metastases
Numbers of metastases
Measured: 18 years
Biomarker indices of disease burden
Surrogate biomarker indices of disease burden (such as hormonal measures)
Measured: 18 years
Metabolic parameter - blood glucose
fasting blood glucose
Measured: 18 years
Metabolic parameter - HbA1c
Hb1Ac
Measured: 18 years
Metabolic parameter - cholesterol
fasting cholesterol (total, LDL, HDL)
Measured: 18 years
Hormonal parameters
hormonal profiles including metanephrines, normetanephrines and metoxytyramine (that will allow for sub-group specification of PPGLs)
Measured: 18 years
Blood pressure profiles
Measurement of 24h blood pressure and ambulatory blood pressure measurments
Measured: 18 years
Cardiac function
Leftventricualr ejection fraction
Measured: 18 years
Disease specific mortality
Disease specific mortality
Measured: 18 years
Overall mortality
Overall mortality
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Nov 2017
- Primary completion1 Nov 2035 (estimated)
- Study completion1 Nov 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To provide evidence whether strict follow-up will result in improvement in clinical outcome parameters as compared to standard care follow-up, patients upon inclusion into the study protocol will be randomized into two groups: * Standard care follow-up group: Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines. * Special care follow-up group: In addition to the information leaflet patients will be actively contacted by the clinical center to increase the likelihood that patients meet recommended follow-up schedules. Stratification will be done for inclusion criteria (newly diagnosed PPGL, previous history of PPGL, gene carrier, presence of malignant PPGL and center).
- Masking
- None (open label)
- Enrolment
- 1,148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Felix Beuschlein
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden, Wuerzburg University Hospital, University of Zurich, Radboud University Medical Center, Lübeck University Clinic, Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor-investigator, Felix Beuschlein, Ludwig-Maximilians - University of Munich
- Investigators
- Felix Beuschlein, M.D., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344016
- Sponsor's protocol ID
- 742-16
- Acronym
- MUPPET
- Status last verified
- Jul 2020
- First submitted
- 2 Nov 2017
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MUPPET-study: Multicenter Pheochromocytoma and Paraganglioma Evaluation for Follow-up Screening, Genetics Sub-Typing, Therapy and Outcome
- ClinicalTrials.gov ID
- NCT03344016
- Acronym / sponsor ID
- MUPPET / 742-16
- Conditions
- Pheochromocytoma, Paraganglioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,148 participants (estimated)
- Lead sponsor
- Felix BeuschleinUniversity, hospital or other
- Collaborators
- Technische Universität Dresden, Wuerzburg University Hospital, University of Zurich, Radboud University Medical Center, Lübeck University Clinic, Ludwig-Maximilians - University of Munich
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2035 (estimated)
- Study completion
- 1 Nov 2040 (estimated)
- First posted
- 17 Nov 2017 (actual)
- 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.
Target population:
Patients with (1) newly diagnosed or (2) past history of pheochromocytomas and paragangliomas (PPGL) or (3) carrier of genetic mutations in known PPGL susceptibility genes.
International multicenter prospective cohort study with randomized intervention (special care follow-up vs. standard care follow-up).
All patients will receive instructions about follow-up at the time point of study inclusion. Patients randomized to the standard care follow-up group will be advised to return annually for follow-up according to current routine practice (without active re-scheduling). In contrast, patients randomized to the special care follow-up group will also be advised to return annually for follow-up but these patients will be actively invited, re-scheduled and reminded by the centers to meet scheduled follow-up appointments.
Detailed description
The long-term goal of the research planned under this protocol is to reduce morbidity and mortality of patients with PPGLs by improving approaches for management, follow-up and therapy of affected patients. As a first step towards attaining this goal, the primary objective of this protocol is to investigate whether standardized follow-up results in improved long-term outcome in terms of less morbidity and mortality as compared. The central hypothesis is that pro-active, structured and periodic disease screening and management of patients at risk for developing PPGLs and other neoplasms can lead to earlier detection of tumors and reduce adverse outcomes associated with cardiovascular, metabolic and oncologic complications of the tumors than standard care follow-up. The underlying rationale is that establishing improved outcomes for patients at risk for PPGLs will enable evidence-based recommendations for disease follow-up and management, thereby establishing wider acceptance and use of outlined practices with ensuing improvements in the health and quality of life of affected patients and their families.
In addition to the primary objective directed at establishing whether standardized and structured follow-up of patients with an increased risk for new events of PPGL (recurrent tumor, new tumor, or metastases) will result in improved longterm outcome, this protocol will enable several secondary objectives to be addressed using clinical (e.g. age, mode of presentation), biochemical, metabolic and genetic characteristics. These include:
- to identify prognostic markers of disease progression
- to assess whether clinical presentation, cardiovascular, metabolic and biochemical phenotype, genetic background and tumor characteristics (location, size, recurrence, pathology) are useful for development of personalized follow-up strategies.
- to investigate whether standardized follow-up affects quality of life
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To provide evidence whether strict follow-up will result in improvement in clinical outcome parameters as compared to standard care follow-up, patients upon inclusion into the study protocol will be randomized into two groups: * Standard care follow-up group: Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines. * Special care follow-up group: In addition to the information leaflet patients will be actively contacted by the clinical center to increase the likelihood that patients meet recommended follow-up schedules. Stratification will be done for inclusion criteria (newly diagnosed PPGL, previous history of PPGL, gene carrier, presence of malignant PPGL and center).
| Arm | Type | Receives |
|---|---|---|
| Standard care follow-up group | No intervention | –Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines. |
| Special care follow-up group | Active comparator | Other: Contact by clinical centerIn addition to the information leaflet patients will be actively contacted by the clinical center to increase the likelihood that patients meet recommended follow-up schedules. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- male and female patients (≥ 5 years of age), who fulfill one or more of the following criteria: (i) Patients with a newly diagnosed PPGL. (ii) Patients with a previous history of PPGLs. (iii) Carrier of genetic mutations known to predispose for the development of PPGLs.
- All subjects must have read, understood and signed the informed consent form, before inclusion into the study protocol. Signed parental consent must be obtained for children with suspected PPGLs who are enrolled in the study.
Key exclusion criteria (3 listed)
- Patients with impaired mental capacity that precludes informed consent.
- Pregnancy does not constitute criteria for exclusion from the protocol. However, in pregnant women no Clonidine testing, no PET scanning, MIBG scanning or contrast CT will be performed.
- Patients at risk from injury from the MRI magnet due to implantable metal or who suffer from anxiety in enclosed spaces are excluded from MRI.
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 |
|---|---|---|
| Contact by clinical centerPatients will be acitvely contacted by the clinical center for follow-up procedure | Other | Special care follow-up group |
Primary outcome
Morbidity
Time frame: 18 years
to investigate whether standardized follow-up for patients at risk for PPGL improves long-term outcome
12 secondary outcomes
Time to recurrence
Time frame: 18 years
Size of recurrent tumors
Time frame: 18 years
Numbers of metastases
Time frame: 18 years
Biomarker indices of disease burden
Time frame: 18 years
Metabolic parameter - blood glucose
Time frame: 18 years
Metabolic parameter - HbA1c
Time frame: 18 years
Metabolic parameter - cholesterol
Time frame: 18 years
Hormonal parameters
Time frame: 18 years
Blood pressure profiles
Time frame: 18 years
Cardiac function
Time frame: 18 years
Disease specific mortality
Time frame: 18 years
Overall mortality
Time frame: 18 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Felix Beuschlein, M.D. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact by clinical center in people with Pheochromocytoma and Paraganglioma, run by Felix Beuschlein 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Jul 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Beuschlein, M.D. (+41 44 255 36 25, felix.beuschlein@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 18 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 9 Jul 2020; AzTrials last refreshed its copy on 26 Oct 2026.