An interventional study of Contact by clinical center in Pheochromocytoma and Paraganglioma, sponsored by Felix Beuschlein. Recruiting at 1 site in Switzerland. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2020-07-09.
Sponsored by Felix Beuschlein · Not applicable, Interventional, and Health services research
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.
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:
158 studies on the registry are indexed under Pheochromocytoma; 57 are open to participants now.
This study's planned enrollment of 1,148 is above the median of 37 across 87 interventional studies indexed under Pheochromocytoma.
Browse Pheochromocytoma studies →Felix Beuschlein is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines.
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.
Other: Contact by clinical center
Patients will be acitvely contacted by the clinical center for follow-up procedure
Morbidity
to investigate whether standardized follow-up for patients at risk for PPGL improves long-term outcome
Time frame: 18 years
Time to recurrence
Time to recurrence
Time frame: 18 years
Size of recurrent tumors
Size of recurrent tumors
Time frame: 18 years
Numbers of metastases
Numbers of metastases
Time frame: 18 years
Biomarker indices of disease burden
Surrogate biomarker indices of disease burden (such as hormonal measures)
Time frame: 18 years
Metabolic parameter - blood glucose
fasting blood glucose
Time frame: 18 years
Metabolic parameter - HbA1c
Hb1Ac
Time frame: 18 years
Metabolic parameter - cholesterol
fasting cholesterol (total, LDL, HDL)
Time frame: 18 years
Hormonal parameters
hormonal profiles including metanephrines, normetanephrines and metoxytyramine (that will allow for sub-group specification of PPGLs)
Time frame: 18 years
Blood pressure profiles
Measurement of 24h blood pressure and ambulatory blood pressure measurments
Time frame: 18 years
Cardiac function
Leftventricualr ejection fraction
Time frame: 18 years
Disease specific mortality
Disease specific mortality
Time frame: 18 years
Overall mortality
Overall mortality
Time frame: 18 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2017 (actual). Primary completion is estimated for Nov 2035, 216 months after the start.
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Felix Beuschlein