Evaluation of follow-up care for patients with pheochromocytoma and paraganglioma
The MUPPET-study: Multicenter Pheochromocytoma and Paraganglioma Evaluation for Follow-up Screening, Genetics Sub-Typing, Therapy and Outcome
This study is testing if a special follow-up care approach can help people with pheochromocytomas and paragangliomas live healthier and longer lives compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1148 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Ludwig-Maximilians - University of Munich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT03344016 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective cohort study aims to improve the management and follow-up of patients with pheochromocytomas and paragangliomas (PPGLs) by comparing two follow-up approaches: standard care versus a proactive special care follow-up. Patients will be randomized into either group, with the special care group receiving active reminders and rescheduling for their follow-up appointments. The study seeks to determine if structured follow-up can lead to better long-term outcomes, including reduced morbidity and mortality associated with these tumors. By establishing effective follow-up practices, the research aims to enhance the quality of life for patients at risk of PPGLs.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 5 years and older with newly diagnosed or a history of PPGLs, or those carrying genetic mutations associated with these tumors.
Not a fit: Patients with impaired mental capacity that prevents informed consent or those with specific medical conditions that exclude them from MRI procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term health outcomes for patients with pheochromocytomas and paragangliomas through better follow-up care.
How similar studies have performed: Other studies have shown promising results with structured follow-up approaches in similar patient populations, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: * 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.
Where this trial is running
Zurich
- University Hospital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Felix Beuschlein, M.D. — University of Zurich
- Study coordinator: Felix Beuschlein, M.D.
- Email: felix.beuschlein@usz.ch
- Phone: +41 44 255 36 25
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.