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
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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UNKNOWN
139 participants
OBSERVATIONAL
2020-10-08
2023-11-01
Brief Summary
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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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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Interventions
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Use of an internet plateform
Use of an internet platform for remote monitoring of patients.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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.
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.
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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