Multicenter Pheochromocytoma and Paraganglioma Evaluation

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03344016

Studienbeginn:
November 2017

Letztes Update:
09.07.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Pheochromocytoma, Paraganglioma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Felix Beuschlein

Collaborator:
Technische Universität Dresden, Wuerzburg University Hospital, University of Zurich, Radboud University Medical Center, Lübeck University Clinic, Ludwig-Maximilians - University of Munich,

Studienleiter

Felix Beuschlein, M.D.
Principal Investigator
University of Zurich

Kontakt

Felix Beuschlein, M.D.
Kontakt:
Phone: +41 44 255 36 25
E-Mail: felix.beuschlein@usz.ch» Kontaktdaten anzeigen

Martin Reincke, M.D.
Kontakt:
Phone: +49 89 4400 52100
E-Mail: martin.reincke@med.uni-muenchen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Zurich
8091 Zurich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Felix Beuschlein, M.D.
Phone: +41 44 255 36 25
E-Mail: felix.beuschlein@usz.ch

Martin Reincke, M.D.
Phone: +49 89 4400 52100
E-Mail: martin.reincke@med.uni-muenchen.de» Ansprechpartner anzeigen

Studien-Informationen

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:

1. to identify prognostic markers of disease progression

2. 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.

3. to investigate whether standardized follow-up affects quality of life

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Morbidity (Time Frame - 18 years):
to investigate whether standardized follow-up for patients at risk for PPGL improves long-term outcome

Secondary outcome:

1. Time to recurrence (Time Frame - 18 years):
Time to recurrence

2. Size of recurrent tumors (Time Frame - 18 years):
Size of recurrent tumors

3. Numbers of metastases (Time Frame - 18 years):
Numbers of metastases

4. Biomarker indices of disease burden (Time Frame - 18 years):
Surrogate biomarker indices of disease burden (such as hormonal measures)

5. Metabolic parameter - blood glucose (Time Frame - 18 years):
fasting blood glucose

6. Metabolic parameter - HbA1c (Time Frame - 18 years):
Hb1Ac

7. Metabolic parameter - cholesterol (Time Frame - 18 years):
fasting cholesterol (total, LDL, HDL)

8. Hormonal parameters (Time Frame - 18 years):
hormonal profiles including metanephrines, normetanephrines and metoxytyramine (that will allow for sub-group specification of PPGLs)

9. Blood pressure profiles (Time Frame - 18 years):
Measurement of 24h blood pressure and ambulatory blood pressure measurments

10. Cardiac function (Time Frame - 18 years):
Leftventricualr ejection fraction

11. Disease specific mortality (Time Frame - 18 years):
Disease specific mortality

12. Overall mortality (Time Frame - 18 years):
Overall mortality

Studien-Arme

No Intervention: Standard care follow-up group
Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines.
Active Comparator: 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.

Geprüfte Regime

Contact by clinical center:
Patients will be acitvely contacted by the clinical center for follow-up procedure

Quelle: ClinicalTrials.gov

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