NCT04573816

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 139 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Pheochromocytoma
• Paraganglioma

Interventions

Type	Name	Description
OTHER	Use of an internet plateform	Use of an internet platform for remote monitoring of patients.

Timeline

• Start date: 2020-10-08
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2020-10-05
• Last updated: 2022-01-19

Locations

1 site across 1 country: France