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Идёт набор NCT06974162

Metagenomics for Ocular Inflammation

— Наблюдательное Uveitis Aqueous Humor Infection

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: Metagenomic sequencing of aqueous humor, Ocular Imaging.
Кому может быть актуально
Состояния в реестре: Uveitis, Aqueous Humor, Infection. Базовые параметры: Без ограничений · 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
Великобритания
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

Metagenomic Sequencing of Ocular Fluids in Patients With Ocular Inflammation

Обзор

The aim of this study is to apply a diagnostic test called 'metagenomic sequencing' to identify the involvement of potential infections in patients with ocular inflammation, where this hasn't been detected by currently available standard testing. For many people with ocular inflammation, no cause is ever found for their disease. In some cases, an infection or infectious trigger is suspected, but currently available tests are inadequate. Metagenomic sequencing can identify almost every globally known infection (bacteria, virus, fungi, parasites) in a sample. Therefore, it has the potential to identify an infection that has caused or triggered ocular inflammation, and as a consequence may help to identify specific treatments. It has the potential to improve our understanding of how to diagnose and treat people with this problem. This study will allow us to test the technique that has been previously optimised for brain infections, on ocular fluids. Participants will be 18 years of age or over and have active ocular inflammation which is suspected to be due to an infection, or an autoimmune process which has been triggered by an infection, but identification of this infection has not been possible using the investigations available as part of standard NHS care. Participants will be identified by the treating clinical team as requiring a sample of fluid from inside of the eye, and some of this fluid will be sent for metagenomic sequencing alongside standard testing. This study will be conducted at Moorfields Eye Hospital, London and will last for approximately a year. Participants will undergo additional non-invasive ocular imaging on the day of their clinic visit, but will not have to attend any additional research visits.

Вмешательства

  • Диагностический тест Metagenomic sequencing of aqueous humor
    Metagenomic Sequencing on aqueous humor surplus to diagnostic requirements
  • Диагностический тест Ocular Imaging
    Ocular imaging with anterior segment OCT, laser flare photometry, confocal microscopy and colour fundus photography.

Первичные конечные точки

  • The percentage of participants who receive a clinically viable result from metagenomic sequencing [Срок оценки: 12 months]
Вторичные конечные точки (1)
  • The number of patients who receive a result that leads to a change in treatment and beneficial outcome from metagenomic sequencing [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 18 years of age or older with the capacity to consent
  • Standard of care has not determined a clinical diagnosis
  • Active ocular inflammation with risk of visual loss
  • Clinically suspected infectious or para-infectious cause of ocular inflammation

Критерии исключения

  • Contraindication to ocular fluid sampling
  • Where an urgent result within 5 days is clinically required

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Великобритания · 1 центр
  • Moorfields Eye Hospital NHS Foundation Trust — London

Публикации

  • Atkinson L, Lee JC, Lennon A, Shah D, Storey N, Morfopoulou S, Harris KA, Breuer J, Brown JR. Untargeted metagenomics protocol for the diagnosis of infection from CSF and tissue from sterile sites. Heliyon. 2023 Sep 9;9(9):e19854. doi: 10.1016/j.heliyon.2023.e19854. eCollection 2023 Sep. PMID 37809666
  • Penner J, Hassell J, Brown JR, Mankad K, Storey N, Atkinson L, Ranganathan N, Lennon A, Lee JCD, Champsas D, Kopec A, Shah D, Venturini C, Dixon G, De S, Hatcher J, Harris K, Aquilina K, Kusters MA, Moshal K, Shingadia D, Worth AJJ, Lucchini G, Merve A, Jacques TS, Bamford A, Kaliakatsos M, Breuer J, Morfopoulou S. Translating metagenomics into clinical practice for complex paediatric neurological PMID 37557958
  • Doan T, Acharya NR, Pinsky BA, Sahoo MK, Chow ED, Banaei N, Budvytiene I, Cevallos V, Zhong L, Zhou Z, Lietman TM, DeRisi JL. Metagenomic DNA Sequencing for the Diagnosis of Intraocular Infections. Ophthalmology. 2017 Aug;124(8):1247-1248. doi: 10.1016/j.ophtha.2017.03.045. Epub 2017 May 16. No abstract available. PMID 28526549

Идентификаторы

NCT: NCT06974162 · CHUC1004 · 25/WM/0072 · 354543

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗