Cohort Primary Hyperparathyroidism
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Primary Hyperparathyroidism. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Prospective Cohort Primary Hyperparathyroidism
Обзор
CoHPT is a prospective, monocentric, observational cohort including all patients diagnosed with primary hyperparathyroidism in Nantes University Hospital, aiming to study the outcomes associated with parathyroidectomy. Clinical and biochemical evaluation is performed at the inclusion, and 6, 12, 36 and 60 months. A biocollection is collected. The main hypotheses are that parathyroidectomy could improve cardiovascular, renal, bone, and cardiovascular outcomes along with quality of life.
Подробное описание
Primaty hyperparathyroidism is the third most frequent endocrine disorder, which only curative treatment is the parathyroidectomy (approximately 8000/year). However, evidences suggest that the mildest forms of PHPT could be safely monitored with simple surveillance. However, to define surgical indications is challenging because data regarding the impach of surgery on several outcomes (namely cardiovascular, bone, renal or quality of life) are controversial.
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
Первичные конечные точки
- Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism [Срок оценки: Between inclusion and 12 months after surgery]
- Change in LDL-cholesterol concentration after surgery [Срок оценки: Between inclusion and 12 months after surgery]
- Change in HDL-cholesterol concentration after surgery [Срок оценки: Between inclusion and 12 months after surgery]
- Change in plasma triglycerides concentration after surgery [Срок оценки: Between inclusion and 12 months after surgery]
- Change in homeostasis model assessment HOMA-IR index after surgery [Срок оценки: Between inclusion and 12 months after surgery]
- Change in homeostasis model assessment HOMA-B index after surgery [Срок оценки: Between inclusion and 12 months after surgery]
- Change in arterial stiffness after surgery [Срок оценки: Between inclusion and 12 months after surgery]
Вторичные конечные точки (12)
- Occurrence of cardiovascular events, after parathyroidectomy for primary hyperparathyroidism [Срок оценки: Between inclusion and 60 months after surgery]
- Change in LDL-cholesterol concentration after surgery [Срок оценки: Between inclusion and 60 months after surgery]
- Change in HDL-cholesterol concentration after surgery [Срок оценки: Between inclusion and 60 months after surgery]
- Change in plasma triglycerides concentration after surgery [Срок оценки: Between inclusion and 60 months after surgery]
- Change in homeostasis model assessment HOMA-IR index after surgery [Срок оценки: Between inclusion and 60 months after surgery]
- Change in homeostasis model assessment HOMA-B index after surgery [Срок оценки: Between inclusion and 60 months after surgery]
- Change in arterial stiffness after surgery [Срок оценки: Between inclusion and 60 months after surgery]
- Change in bone mineral density after parathyroidectomy [Срок оценки: Between inclusion and 12 months after surgery]
- Change in bone-specific alkaline phosphatases [Срок оценки: Between inclusion and 12 months after surgery]
- Change in P1NP [Срок оценки: Between inclusion and 12 months after surgery]
- Change in plasma CTX [Срок оценки: Between inclusion and 12 months after surgery]
- Change in bone mineral density after parathyroidectomy [Срок оценки: Between inclusion and 60 months after surgery]
Критерии участия
Критерии включения
- Age > 18
Критерии исключения
- Age < 18
- Pregnancy / lactation
- Adults underguardianship
- Secondary/tertiary hyperparathyroidism
- Multiple endocrine neoplasia
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Nantes University Hospital — Nantes
Публикации
- Loison M, Wargny M, Caillard C, Guillot P, Le Bras M, Cariou B, Blanchard C, Mirallie E, Frey S. Radius Bone Mineral Density Measurement Is Essential During Initial PHPT Workup: Results of a Retrospective Study on 400 Patients. World J Surg. 2026 Feb;50(2):441-450. doi: 10.1002/wjs.70223. Epub 2026 Jan 4. PMID 41486083
- 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. PMID 36917123
Идентификаторы
NCT: NCT05469087 · RC15_0424