Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma (e-PPGL)

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.

The 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.

Study Overview

• Status: Recruiting
• Conditions: Pheochromocytoma; Paraganglioma
• Intervention / Treatment: Other: Use of an internet plateform

Detailed Description

Patients will be included in a follow-up consultation or during a telephone contact prior to a consultation.

The 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.

• Study Type: Observational
• Enrollment (Anticipated): 139

Contacts and Locations

• Study Contact: Name: Laurence AMAR, MD, PhD; Phone Number: 33 156 093 771; Email: laurence.amar@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hopital Europeen Georges Pompidou
    • Contact: Laurence AMAR, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with pheochromocytoma or paraganglioma surgery

Description

Inclusion Criteria:

• Patient at least 18 years old
• Follow-up after surgery of a pheochromocytoma or a paraganglioma at the European Hospital Georges Pompidou (Paris, France)
• Free from recurrences and / or metastases at inclusion
• Non-opposition of participation in research

Exclusion Criteria:

• Lack of internet access
• Patient not understanding French
• Patient living abroad, unable to come for consultation
• Patient with co-morbidity involving life threatening within one year of inclusion
• Pregnant or breastfeeding woman

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of the program	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	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reminders	Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): number of reminders.	13 months
Schedule compliance	Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): compliance with planned deadlines.	13 months
Data filling	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).	13 months
Acceptability	Evaluate patient acceptability and satisfaction with the use of the solution using a satisfaction questionnaire.	13 months
Lost to follow-up	Establishment of an e-cohort study to evaluate the rate of patients lost to follow-up compared to the historical cohort.	37 months
Prognostic factors for recurrence.	Establishment of an e-cohort study to look for prognostic factors for recurrence.	37 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Laurence AMAR, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2020
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: follow-up; recurrence; Pheochromocytoma; e-consultation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Pheochromocytoma; Paraganglioma
• Other Study ID Numbers: D20170803; 2020-A00144-35 (OTHER: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Two years after the last publication

IPD Sharing Access Criteria

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.

Teams 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).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No