NCT04573816

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

October 8, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

3.1 years

First QC Date

September 28, 2020

Last Update Submit

January 17, 2022

Conditions

PheochromocytomaParaganglioma

Keywords

follow-uprecurrencee-consultationPheochromocytoma

Outcome Measures

Primary Outcomes (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

    13 months

Secondary Outcomes (6)

  • Reminders

    13 months

  • Schedule compliance

    13 months

  • Data filling

    13 months

  • Acceptability

    13 months

  • Lost to follow-up

    37 months

  • +1 more secondary outcomes

Interventions

Use of an internet plateformOTHER

Use of an internet platform for remote monitoring of patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pheochromocytoma or paraganglioma surgery

You may qualify if:

  • Patient at least 18 years old
  • Follow-up after surgery of a pheochromocytoma or a paraganglioma at the European Hospital Georges Pompidou (Paris, France)
  • Non-opposition of participation in research

You may not qualify if:

  • Lack of internet access
  • Patient not understanding French
  • Patient living abroad, unable to come for consultation
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital européen Georges Pompidou

Paris, 75015, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 22351478BACKGROUND

  • 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.

    PMID: 27048283BACKGROUND

MeSH Terms

Conditions

PheochromocytomaParagangliomaRecurrence

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laurence AMAR, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence AMAR, MD, PhD

CONTACT

33 156 093 771laurence.amar@aphp.fr

Sabrina BOUDIF, MSc

CONTACT

+33156095976sabrina.boudif@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

October 8, 2020

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Two years after the last publication
Access Criteria
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team.Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation(GDPR).

Locations

FR(1)