Меню
Идёт набор NCT04695028

CRYSTALILLE Cohort: Getting the Whole Picture of Crystal-related Arthropathies

— Наблюдательное Gout Chondrocalcinosis Hydroxyapatite

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
В протоколе указаны: Data collection.
Кому может быть актуально
Состояния в реестре: Gout, Chondrocalcinosis, Hydroxyapatite. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Data Collection for the Constitution of an Observatory for Patients Suffering From Microcrystalline Rheumatism With Morphological Phenotyping

Обзор

The objective of this research is to collect data to create an observatory of microcrystalline rheumatism (gout and calcium-crystal rheumatism) in patients treated at the Groupement des Hôpitaux de l'Institut Catholique de Lille, in order to better understand the disease and improve patient care, in particular with the help of medical imaging.

Подробное описание

All patients already included in another observational study set up in 2016 and meeting the eligibility criteria may be included in this study. An information letter will be sent to them by mail. If they wish to oppose to the use of their data, they can then return the objection form.

This sample will be supplemented by new patients who are recruited during a classic rheumatology consultation. The investigator will propose the study to all patients meeting the inclusion and non-inclusion criteria.

They will be informed of the objectives of the study and their rights. For patients who agree to participate in the study, sociodemographic and clinical characteristics will be collected.

Depending on the usual care, they will benefit from an ultrasound and/or a dual energy scanner (M0). Imaging data will be collected. Routine clinical follow-up is then carried out in consultation, with collection of clinical and biological evolution data, and morphological data if necessary if imaging is rechecked, until the patient is lost to follow-up or the follow-up is interrupted at the GHICL for any reason.

Available quarterly or semi-annual data will be collected.

Вмешательства

  • Другое Data collection
    The following data will be collected by the physician: sociodemographic profile, clinical manifestations, comorbidities, laboratory tests,etc. Diagnostic performance of different imagery techniques, performance of crystal deposit quantification in ultrasound and Dual-energy computed tomography (DECT), link between co-morbidities and volume of baseline crystal deposits then during monitoring, link between co-morbidities (including cardiovascular events and new diagnoses of co-morbidity) and vasc

Первичные конечные точки

  • Diagnosis of microcrystalline rheumatism [Срок оценки: day 0]
  • Weight [Срок оценки: day 0]
  • Height [Срок оценки: day 0]
  • Index body mass [Срок оценки: day 0]
  • Comorbidities [Срок оценки: day 0]
  • Number of rheumatic flares [Срок оценки: day 0]
  • Intensity of rheumatic flares [Срок оценки: day 0]
  • Identification of subcutaneous tophi [Срок оценки: day 0]
  • Uricemia [Срок оценки: day 0]
  • Renal function panel [Срок оценки: day 0]

Критерии участия

Критерии включения

  • Diagnosis of gout according to American College of Rheumatology /European League Against Rheumatism (ACR/EULAR) 2015 criteria OR diagnosis of calcium pyrophosphate dihydrate crystal deposition disease (CPPD) based on EULAR 2011 recommendations OR diagnosis of hydroxyapatite crystal rheumatism (HCR) according to a typical clinical sequence and demonstration of compatible calcium deposits on imaging
  • patient who will benefit or has benefited from an ultrasound and/or DECT evaluation of microcrystalline deposits
  • clinical suspicion of microcrystalline rheumatism requiring further imaging to confirm the diagnosis

Критерии исключения

  • Refusal or contra-indication to perform ultrasound or dual energy scanning.
  • Patient's opposition to the use of his or her health data for research purposes
  • Patient under guardianship or curatorship
  • Pregnant woman
  • Person not affiliated to a social security scheme or entitled to a social security benefit

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • GHICL- Hôpital Saint Philibert — Lomme

Идентификаторы

NCT: NCT04695028 · RC-P00101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗