Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04573816
Status:
UNKNOWN
Last Update Posted:
2022-01-19
First Post:
2020-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010673', 'term': 'Pheochromocytoma'}, {'id': 'D010235', 'term': 'Paraganglioma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 139}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2020-09-28', 'studyFirstSubmitQcDate': '2020-09-28', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of the program', 'timeFrame': '13 months', 'description': 'Proportion of patients with a concordance score greater than or equal to 85% between the data collected in consultation and those entered by the patient via the optimized remote monitoring program'}], 'secondaryOutcomes': [{'measure': 'Reminders', 'timeFrame': '13 months', 'description': 'Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): number of reminders.'}, {'measure': 'Schedule compliance', 'timeFrame': '13 months', 'description': 'Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): compliance with planned deadlines.'}, {'measure': 'Data filling', 'timeFrame': '13 months', 'description': 'Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): completion of questionnaires (clinical data, blood pressure measurement and biological results).'}, {'measure': 'Acceptability', 'timeFrame': '13 months', 'description': 'Evaluate patient acceptability and satisfaction with the use of the solution using a satisfaction questionnaire.'}, {'measure': 'Lost to follow-up', 'timeFrame': '37 months', 'description': 'Establishment of an e-cohort study to evaluate the rate of patients lost to follow-up compared to the historical cohort.'}, {'measure': 'Prognostic factors for recurrence.', 'timeFrame': '37 months', 'description': 'Establishment of an e-cohort study to look for prognostic factors for recurrence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['follow-up', 'recurrence', 'e-consultation', 'Pheochromocytoma'], 'conditions': ['Pheochromocytoma', 'Paraganglioma']}, 'referencesModule': {'references': [{'pmid': '22351478', 'type': 'BACKGROUND', 'citation': 'Amar L, Fassnacht M, Gimenez-Roqueplo AP, Januszewicz A, Prejbisz A, Timmers H, Plouin PF. Long-term postoperative follow-up in patients with apparently benign pheochromocytoma and paraganglioma. Horm Metab Res. 2012 May;44(5):385-9. doi: 10.1055/s-0031-1301339. Epub 2012 Feb 20.'}, {'pmid': '27048283', 'type': 'BACKGROUND', 'citation': 'Plouin PF, Amar L, Dekkers OM, Fassnacht M, Gimenez-Roqueplo AP, Lenders JW, Lussey-Lepoutre C, Steichen O; Guideline Working Group. European Society of Endocrinology Clinical Practice Guideline for long-term follow-up of patients operated on for a phaeochromocytoma or a paraganglioma. Eur J Endocrinol. 2016 May;174(5):G1-G10. doi: 10.1530/EJE-16-0033.'}]}, 'descriptionModule': {'briefSummary': 'Pheochromocytomas and paragangliomas (PPGL) are rare tumors treated by surgical excision. During follow-up, more than 15% of patients will have recurrences in the form of new tumors, locoregional recurrence or metastases. This subgroup is initially not identifiable. It is therefore usual to perform annual monitoring of all patients throughout their lives by questioning and measuring blood pressure during a medical consultation and by measuring urinary or plasma metanephrines and normetanephrines.\n\nThe main objective of this prospective monocentric study is to evaluate the reliability of an optimized remote monitoring program in comparison to a usual in-clinic monitoring of patients surgically-cured and tumor-free at the time of inclusion.', 'detailedDescription': 'Patients will be included in a follow-up consultation or during a telephone contact prior to a consultation.\n\nThe period of follow-up by internet and the date of the next consultation will be fixed. This assessment is annual according to current recommendations. In the two months prior to the consultation, patients will fill out a questionnaire and transcribe their blood pressure self-measurement results as well as their biological assessment on a dedicated, approved data-hosting platform (internet application named HERMES). During the consultation, these items will be collected again without the knowledge of the results entered by the patient on the data hosting site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pheochromocytoma or paraganglioma surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient at least 18 years old\n* Follow-up after surgery of a pheochromocytoma or a paraganglioma at the European Hospital Georges Pompidou (Paris, France)\n* Free from recurrences and / or metastases at inclusion\n* Non-opposition of participation in research\n\nExclusion Criteria:\n\n* Lack of internet access\n* Patient not understanding French\n* Patient living abroad, unable to come for consultation\n* Patient with co-morbidity involving life threatening within one year of inclusion\n* Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT04573816', 'acronym': 'e-PPGL', 'briefTitle': 'Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma', 'orgStudyIdInfo': {'id': 'D20170803'}, 'secondaryIdInfos': [{'id': '2020-A00144-35', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Use of an internet plateform', 'type': 'OTHER', 'description': 'Use of an internet platform for remote monitoring of patients.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence AMAR, PhD', 'role': 'CONTACT'}], 'facility': 'Hopital européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Laurence AMAR, MD, PhD', 'role': 'CONTACT', 'email': 'laurence.amar@aphp.fr', 'phone': '33 156 093 771'}, {'name': 'Sabrina BOUDIF, MSc', 'role': 'CONTACT', 'email': 'sabrina.boudif@aphp.fr', 'phone': '+33156095976'}], 'overallOfficials': [{'name': 'Laurence AMAR, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team.Collaboration will be fostered.\n\nTeams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation(GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}