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Pheochromocytomae-PPGLNCT04573816

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

An observational study of Pheochromocytoma and Paraganglioma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pheochromocytoma, Paraganglioma
What is being tested?
Use of an internet plateform
How many people
132 participants
Where
1 siteFrance
Study dates
19 Oct 2020to 9 Oct 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with pheochromocytoma or paraganglioma surgery

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital européen Georges Pompidou

    Paris, 75015

Other trials in France

About this study

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.

Read the 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.

Being tested
Use of an internet plateform
Keywords
follow-up, recurrence, e-consultation, Pheochromocytoma
Medical subject headings
Pheochromocytoma, Paraganglioma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of an internet plateformOther

    Use of an internet platform for remote monitoring of patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reliability of the program

    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

    Measured: 13 months

Secondary outcomes (6)

  1. Reminders

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

    Measured: 13 months

  2. Schedule compliance

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

    Measured: 13 months

  3. Data filling

    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).

    Measured: 13 months

  4. Acceptability

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

    Measured: 13 months

  5. Lost to follow-up

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

    Measured: 37 months

  6. Prognostic factors for recurrence.

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

    Measured: 37 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start19 Oct 2020
  3. Primary completion9 Oct 2023
  4. Study completion9 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04573816
Sponsor's protocol ID
D20170803
Other IDs
2020-A00144-35
Acronym
e-PPGL
Status last verified
Jul 2026
First submitted
28 Sep 2020
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 22351478

  • 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.

    PubMed 27048283

Questions about this trial

What is this clinical trial studying?

An observational study of Pheochromocytoma and Paraganglioma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reliability of the program (time frame: 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04573816, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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