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Completed

NCT Number: NCT04573816

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

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.

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Key information

Conditions

Pheochromocytoma Disease Attributes Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Paraganglioma Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital européen Georges Pompidou

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of an internet plateform

Other

Use of an internet platform for remote monitoring of patients.

Primary outcomes

  1. Reliability of the program

    Time frame: 13 months

    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

Secondary outcomes

  1. Reminders

    Time frame: 13 months

    Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): number of reminders.

  2. Schedule compliance

    Time frame: 13 months

    Evaluate feasibility of the ability of patients to actively participate in their care pathway (self care; self monitoring): compliance with planned deadlines.

  3. Data filling

    Time frame: 13 months

    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).

  4. Acceptability

    Time frame: 13 months

    Evaluate patient acceptability and satisfaction with the use of the solution using a satisfaction questionnaire.

  5. Lost to follow-up

    Time frame: 37 months

    Establishment of an e-cohort study to evaluate the rate of patients lost to follow-up compared to the historical cohort.

  6. Prognostic factors for recurrence.

    Time frame: 37 months

    Establishment of an e-cohort study to look for prognostic factors for recurrence.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: e-PPGL

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2020
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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