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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RECRUITING
403 participants
OBSERVATIONAL
2016-03-31
2027-02-24
Brief Summary
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Detailed Description
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CoHPT is a prospective, monocentric, observational cohort including all consecutive patients diagnosed with sporadic primary hyperparathyroidism in Nantes University Hospital aiming to study the outcomes associated with parathyroidectomy. Patients are followed even if surgery is not performed.
A systematic clinical and biochemical evaluation is performed at the inclusion, and 6, 12, 36 and 60 months. These informations include demographic and general medical data, pre-operative imaging exams, post-operative outcomes, histopathological analysis, evaluation of the impact of primary hyperparathyroidism and its surgery on target organs (bone, kidney, cardiovascular) and quality of life. Fasting blood samples are also collected to constitute a biocollection, in order to measure biomarkers related to the bone remodeling and the cardiovascular risk.
The objectives are:
* To know the long-term consequences of the primary hyperparathyroidism treatment or observation.
* To better define the surgical indications
* To better understand the mechanisms of the cardiovascular impairment by using the biocollection
* To study the medico-economics consequences of the surgical management versus simple surveillance
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy / lactation
* Adults underguardianship
* Secondary/tertiary hyperparathyroidism
* Multiple endocrine neoplasia
18 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Nantes University Hospital
OTHER
Responsible Party
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Locations
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Nantes University Hospital
Nantes, Loire-Atlantique, France
Countries
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Central Contacts
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References
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Frey S, Perrot B, Caillard C, Le Bras M, Gerard M, Blanchard C, Cariou B, Wargny M, Mirallie E. Parathyroidectomy for primary hyperparathyroidism: effect on quality of life after 3 years - a prospective cohort study. Int J Surg. 2023 Mar 1;109(3):364-373. doi: 10.1097/JS9.0000000000000282.
Other Identifiers
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RC15_0424
Identifier Type: -
Identifier Source: org_study_id
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