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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Paraganglioma; Pheochromocytoma

Treatments: Other: Use of an internet plateform

Study type: Observational

Funder types: Other

Identifiers

NCT04573816

D20170803

2020-A00144-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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