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Multicenter Pheochromocytoma and Paraganglioma Evaluation

ConditionsPheochromocytomaParaganglioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorFelix Beuschlein

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Contact by clinical center

    Other intervention

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

Treatment groups

1,148 Participants
are divided into 2 treatment groups
Group A: Standard care follow-up groupNo intervention 0 interventions
Group B: Special care follow-up groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Morbidity

to investigate whether standardized follow-up for patients at risk for PPGL improves long-term outcome

Time frame
18 years

Secondary outcomes

1

Time to recurrence

Time to recurrence

Time frame
18 years
2

Size of recurrent tumors

Size of recurrent tumors

Time frame
18 years
3

Numbers of metastases

Numbers of metastases

Time frame
18 years
4

Biomarker indices of disease burden

Surrogate biomarker indices of disease burden (such as hormonal measures)

Time frame
18 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Felix Beuschlein

Lead sponsor

Ludwig-Maximilians - University of Munich

Sponsor institution

Technische Universität Dresden

Collaborator

Wuerzburg University Hospital

Collaborator

University of Zurich

Collaborator

Radboud University Medical Center

Collaborator

Lübeck University Clinic

Collaborator

Ludwig-Maximilians - University of Munich

Collaborator

Source ClinicalTrials.gov
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