Multicenter Pheochromocytoma and Paraganglioma Evaluation

  • STATUS
    Recruiting
  • End date
    Nov 1, 2040
  • participants needed
    1148
  • sponsor
    Felix Beuschlein
Updated on 24 January 2021
special care
paraganglioma
pheochromocytoma
adrenal pheochromocytoma

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. 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.

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

Details
Condition Pheochromocytoma, Paraganglioma, Malignant Pheochromocytoma/Paraganglioma, Malignant Pheochromocytoma/Paraganglioma, phaeochromocytoma, paragangliomas, adrenal pheochromocytoma
Treatment Contact by clinical center
Clinical Study IdentifierNCT03344016
SponsorFelix Beuschlein
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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