Clinical trial NCT04573816: Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma
Official title: Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pheochromocytoma
Paraganglioma
Keywords: follow-up
recurrence
e-consultation
Pheochromocytoma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pheochromocytoma or paraganglioma surgery

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliability of the program
timeFrame: 13 months
Secondary outcomes:
measure: Reminders
timeFrame: 13 months
measure: Schedule compliance
timeFrame: 13 months
measure: Data filling
timeFrame: 13 months
measure: Acceptability
timeFrame: 13 months
measure: Lost to follow-up
timeFrame: 37 months
measure: Prognostic factors for recurrence.
timeFrame: 37 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital européen Georges Pompidou
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurence AMAR, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.