Multicenter Pheochromocytoma and Paraganglioma Evaluation

NCT03344016 | Recruiting

• 1 other identifier: 742-16
• Study Type: interventional
• Target: 1,148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pheochromocytoma; Paraganglioma

Outcome Measures

Primary Outcomes (1)

• Morbidity

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

  18 years

Secondary Outcomes (12)

• Time to recurrence

  18 years

• Size of recurrent tumors

  18 years

• Numbers of metastases

  18 years

• Biomarker indices of disease burden

  18 years

• Metabolic parameter - blood glucose

  18 years

Study Arms (2)

Standard care follow-up group

NO INTERVENTION

Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines.

Special care follow-up group

ACTIVE COMPARATOR

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

Interventions

Contact by clinical center OTHER

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

Special care follow-up group

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with impaired mental capacity that precludes informed consent.
• 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.

Sponsors & Collaborators

• Felix Beuschlein: lead
• 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

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Felix Beuschlein, M.D.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Beuschlein, M.D.

CONTACT

+41 44 255 36 25; felix.beuschlein@usz.ch

Martin Reincke, M.D.

CONTACT

+49 89 4400 52100; martin.reincke@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: To provide evidence whether strict follow-up will result in improvement in clinical outcome parameters as compared to standard care follow-up, patients upon inclusion into the study protocol will be randomized into two groups: * Standard care follow-up group: Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines. * 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. Stratification will be done for inclusion criteria (newly diagnosed PPGL, previous history of PPGL, gene carrier, presence of malignant PPGL and center).

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 17, 2017
• Study Start: November 1, 2017
• Primary Completion (Estimated): November 1, 2035
• Study Completion (Estimated): November 1, 2040
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

CH (1)