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

NCT ID: NCT04573816

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-08

Study Completion Date

2023-11-01

Brief Summary

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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

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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

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Pheochromocytoma Paraganglioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Use of an internet plateform

Use of an internet platform for remote monitoring of patients.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurence AMAR, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital européen Georges Pompidou

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laurence AMAR, MD, PhD

Role: CONTACT

33 156 093 771

Sabrina BOUDIF, MSc

Role: CONTACT

+33156095976

Facility Contacts

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Laurence AMAR, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22351478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27048283 (View on PubMed)

Other Identifiers

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2020-A00144-35

Identifier Type: OTHER

Identifier Source: secondary_id

D20170803

Identifier Type: -

Identifier Source: org_study_id

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