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Набор по приглашению NCT06722456

Assessment of Non-invasive Tools for Detecting Active Inflammatory Bowel Disease

— Наблюдательное Inflammatory Bowel Disease (IBD) Crohn Disease (CD) Ulcerative Colitis (UC)

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: Analysis of protein signatures in stool samples.
Кому может быть актуально
Состояния в реестре: Inflammatory Bowel Disease (IBD), Crohn Disease (CD), Ulcerative Colitis (UC). 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
Канада
Следующий шаг
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Официальное название

Set-up of Mass Spectrometry-based Stool Tests for Improving the Diagnosis and Management of Inflammatory Bowel Disease

Обзор

Part of the success of the treatment of people living with inflammatory bowel diseases (IBD) depends on the information that the doctor can obtain from the different clinical tests. Some of these tests are invasive such as the colonoscopy but other such the fecal calprotectin test, which measures intestinal inflammation, are non-invasive and useful to evaluate the success of the treatments. Unfortunately, the results from the non-invasive tests are not always clear and need to be complete with invasive tests for the right diagnosis. The aim of this research is to test new stool markers for assisting the gastroenterologist to diagnose inflammatory bowel conditions including Crohn's disease (CD) and ulcerative colitis (UC) and to carefully monitoring the effects of medications on remission. We are using applications based on the use of mass spectrometry for identifying the proteins that are released by the host in the stools. We have identified more than 400 proteins in total. Based on informatics, we have been able to produce lists of unique stool proteins that can rapidly inform the doctor if the person has an IBD, whether it is a CD or an UC and, more importantly for the treatment, if the IBD is active or in remission. The purpose of this study is to validate these protein markers in a blind test, where the real diagnosis will only be revealed after the analysis of the samples. This study will bring a new power tool to assist the gastroenterologist in the treatment of people living with IBD.

Вмешательства

  • Диагностический тест Analysis of protein signatures in stool samples
    Stool protein signatures are to be established in parallel to standard clinical evaluation of the intestinal inflammatory activity.

Первичные конечные точки

  • Scoring intestinal inflammation from stool protein analyses [Срок оценки: From enrolment to the end of full data compilation, assessed up to 15 months]
Вторичные конечные точки (3)
  • To compare activity scores deduced from proteomics analyses to the results from colonoscopy and pathology. [Срок оценки: From enrolment to the end of full data compilation, assessed up to 15 months]
  • To compare activity scores deduced from proteomics analyses to the results from pathology. [Срок оценки: From enrolment to the end of full data compilation, assessed up to 15 months]
  • To compare activity scores deduced from proteomics analyses to the results from fecal calprotectin. [Срок оценки: From enrolment to the end of full data compilation, assessed up to 15 months]

Критерии участия

Критерии включения

  • Be affected with one of the two main inflammatory bowel diseases (Crohn's disease of ulcerative colitis).
  • Be invited to participate on the base of a routine follow up by their gastroenterologist.
  • Be scheduled for a calprotectin test and a colonoscopy.
  • Accept to participate and provide an extra stool sample for analysis.

Критерии исключения

  • Having no history of inflammatory bowel disease.
  • Be affected with an history of gastrointestinal disease other than Crohn disease or ulcerative colitis.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Канада · 1 центр
  • Centre de recherche of the CIUSSS de l'Estrie-CHUS — Sherbrooke

Публикации

  • Shajari E, Gagne D, Malick M, Roy P, Noel JF, Gagnon H, Brunet MA, Delisle M, Boisvert FM, Beaulieu JF. Application of SWATH Mass Spectrometry and Machine Learning in the Diagnosis of Inflammatory Bowel Disease Based on the Stool Proteome. Biomedicines. 2024 Feb 1;12(2):333. doi: 10.3390/biomedicines12020333. PMID 38397935

Идентификаторы

NCT: NCT06722456 · 90-18A

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗