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Идёт набор NCT06956703

NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

— Наблюдательное Gastro-Intestinal Disorder Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases

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: Gastro-Intestinal Disorder, Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases. Базовые параметры: от 16 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants. The main question it aims to answer is: Are there differences in inflammatory markers between IBD and non-IBD (control) participants.

Подробное описание

A cohort study in patients with moderate to severely active Crohns Disease (CD) and Ulcerative Colitis (UC) who are switching to new targeted biologic therapy (with a different mode of action) - onto either anti-TNFα therapy or vedolizumab for UC or onto anti-TNFα therapy or ustekinumab or upadacitinib for CD and undergoing routine endoscopic assessments as part of normal clinical practice.

The investigator will also recruit participants without these conditions (controls) who are due for a lower GI colonoscopy as part of the UK national bowel cancer screening programme or on any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.

CD \& UC patients will provide blood and stool samples at 3 timepoints (baseline, 3mths, 12mths) as well as extra tissue biopsies taken at standard care endoscopies within 12mths. Controls will provide a blood sample and stool sample as well as extra tissue biopsies taken at standard care colonoscopies.

Samples will be analysed to characterise any observable traits (phenotype) and molecular variability in patients which may be associated with clinical response to the treatment.

The investigator hopes the information gained from this study may help improve the understanding of Inflammatory Bowel Diseases (IBD) and help to develop better ways of treating the condition and predicting the course of the disease and how patients may respond to different treatments.

Первичные конечные точки

  • The comparison of the IL-23/Th17 inflammatory axis between IBD and healthy control samples [Срок оценки: Baseline, Month 3 and Month 12]
Вторичные конечные точки (2)
  • Characterisation of IL-23/Th17 inflammatory axis within IBD biosamples stratified by prior biologic exposure [Срок оценки: Baseline, Month 3 and Month 12]
  • Comparison of mRNA sequencing readouts, characterisation of tissue and immune cell populations, characterisation of protein expression and characterisation of microbial species in the stool and tissue [Срок оценки: Baseline, Month 3 and Month 12]

Критерии участия

Критерии включения

1\. Provision of signed and dated, written informed consent before any study specific procedures

AND

2a. Patients of at least 16 years of age with active Crohn's disease defined as: CRP > = 5 mg/L OR FCP > = 250 μg/g OR Visible ulcerations on ileocolonoscopy with a total SES-CD > = 7, or > = 4 if disease is confined to the terminal ileum OR visable active disease on cross-sectional imaging. Are switching to a new mechanism of action (MOA) onto anti-TNF therapy or ustekinumab or upadacitinib

OR

2b. Patients of at least 16 years (no upper age limit) with active UC defined as: CRP > = 5 mg/L OR FCP > = 250 μg/g OR Mayo endoscopy subscore > = 2. Are switching to a new mechanism of action (MOA) onto either anti-TNFα therapy or vedolizumab

OR

2c. Non-IBD participants who are attending for a lower GI colonoscopy at any participating site. On any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.

Критерии исключения

  • Inability to give informed consent
  • Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human immunodeficiency virus (HIV)
  • An ongoing infection requiring treatment
  • Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures
  • Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit.
  • Current diagnosis of cancer
  • Having received a solid organ or stem cell transplant
  • Having received a transfusion of blood, plasma, or platelets within 120 days prior to enrolment
  • Confirmed pregnancy at time of enrolment
  • For non-IBD participants: A prior history of IBD (CD, UC, microscopic colitis, indeterminate colitis or IBD unspecified)
  • Clinical judgement by the investigator that the patient should not participate in the study
  • Under 16yrs of age

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • University of Nottingham — Nottingham

Идентификаторы

NCT: NCT06956703 · 22GA031

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗