Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT03344016
Status:
RECRUITING
Last Update Posted:
2020-07-09
First Post:
2017-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Pheochromocytoma and Paraganglioma Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010673', 'term': 'Pheochromocytoma'}, {'id': 'D010235', 'term': 'Paraganglioma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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:\n\n* Standard care follow-up group: Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines.\n* 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.\n\nStratification will be done for inclusion criteria (newly diagnosed PPGL, previous history of PPGL, gene carrier, presence of malignant PPGL and center).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1148}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2040-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2017-11-10', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': '18 years', 'description': 'to investigate whether standardized follow-up for patients at risk for PPGL improves long-term outcome'}], 'secondaryOutcomes': [{'measure': 'Time to recurrence', 'timeFrame': '18 years', 'description': 'Time to recurrence'}, {'measure': 'Size of recurrent tumors', 'timeFrame': '18 years', 'description': 'Size of recurrent tumors'}, {'measure': 'Numbers of metastases', 'timeFrame': '18 years', 'description': 'Numbers of metastases'}, {'measure': 'Biomarker indices of disease burden', 'timeFrame': '18 years', 'description': 'Surrogate biomarker indices of disease burden (such as hormonal measures)'}, {'measure': 'Metabolic parameter - blood glucose', 'timeFrame': '18 years', 'description': 'fasting blood glucose'}, {'measure': 'Metabolic parameter - HbA1c', 'timeFrame': '18 years', 'description': 'Hb1Ac'}, {'measure': 'Metabolic parameter - cholesterol', 'timeFrame': '18 years', 'description': 'fasting cholesterol (total, LDL, HDL)'}, {'measure': 'Hormonal parameters', 'timeFrame': '18 years', 'description': 'hormonal profiles including metanephrines, normetanephrines and metoxytyramine (that will allow for sub-group specification of PPGLs)'}, {'measure': 'Blood pressure profiles', 'timeFrame': '18 years', 'description': 'Measurement of 24h blood pressure and ambulatory blood pressure measurments'}, {'measure': 'Cardiac function', 'timeFrame': '18 years', 'description': 'Leftventricualr ejection fraction'}, {'measure': 'Disease specific mortality', 'timeFrame': '18 years', 'description': 'Disease specific mortality'}, {'measure': 'Overall mortality', 'timeFrame': '18 years', 'description': 'Overall mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pheochromocytoma', 'Paraganglioma']}, 'descriptionModule': {'briefSummary': 'Target population:\n\nPatients with (1) newly diagnosed or (2) past history of pheochromocytomas and paragangliomas (PPGL) or (3) carrier of genetic mutations in known PPGL susceptibility genes.\n\nInternational multicenter prospective cohort study with randomized intervention (special care follow-up vs. standard care follow-up).\n\nAll 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.', 'detailedDescription': '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.\n\nIn 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:\n\n1. to identify prognostic markers of disease progression\n2. 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.\n3. to investigate whether standardized follow-up affects quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nmale 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.\n\nAll 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.\n\nExclusion Criteria:\n\n* Patients with impaired mental capacity that precludes informed consent.\n* 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.\n* 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.'}, 'identificationModule': {'nctId': 'NCT03344016', 'acronym': 'MUPPET', 'briefTitle': 'Multicenter Pheochromocytoma and Paraganglioma Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'The MUPPET-study: Multicenter Pheochromocytoma and Paraganglioma Evaluation for Follow-up Screening, Genetics Sub-Typing, Therapy and Outcome', 'orgStudyIdInfo': {'id': '742-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard care follow-up group', 'description': 'Patients will receive an information leaflet (see appendix), which advises on recommended routine follow-up according to international guidelines.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Special care follow-up group', 'description': '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.', 'interventionNames': ['Other: Contact by clinical center']}], 'interventions': [{'name': 'Contact by clinical center', 'type': 'OTHER', 'description': 'Patients will be acitvely contacted by the clinical center for follow-up procedure', 'armGroupLabels': ['Special care follow-up group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Felix Beuschlein, M.D.', 'role': 'CONTACT', 'email': 'felix.beuschlein@usz.ch', 'phone': '+41 44 255 36 25'}, {'name': 'Martin Reincke, M.D.', 'role': 'CONTACT', 'email': 'martin.reincke@med.uni-muenchen.de', 'phone': '+49 89 4400 52100'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Felix Beuschlein, M.D.', 'role': 'CONTACT', 'email': 'felix.beuschlein@usz.ch', 'phone': '+41 44 255 36 25'}, {'name': 'Martin Reincke, M.D.', 'role': 'CONTACT', 'email': 'martin.reincke@med.uni-muenchen.de', 'phone': '+49 89 4400 52100'}], 'overallOfficials': [{'name': 'Felix Beuschlein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Felix Beuschlein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technische Universität Dresden', 'class': 'OTHER'}, {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, {'name': 'University of Zurich', 'class': 'OTHER'}, {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, {'name': 'Lübeck University Clinic', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Felix Beuschlein', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}