ISRCTN12203379进行中（未招募）Unknown
Cellular and molecular profiling of human primary sclerosing cholangitis (PSC)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Eligible participants must fulfil the criteria set out below, as related to the sample type in question.Peripheral blood:1.Adults (age 18 – 75 years).2.Be able to provide written (signed) informed consent.3.Be willing and able to comply with routine clinic visits and study-related procedures.4.Be able to understand and complete study-related questionnaires.5.Liver disease populations - participants must have an established diagnosis of any of the following conditions: 5.1.PSC5.2.PBC5.3.MASLD6.IBD alone populations - participants must have an established diagnosis of one of the following, without a concurrent diagnosis of PSC:6.1.Ulcerative colitis (UC) 6.2.Crohn’s disease with colonic involvement 6.3.IBD unclassified with colonic involvement7.Healthy controls -defined as participants who do not have present or previous gastrointestinal or liver disease. Participants with functional gastrointestinal disorder (FGID) can be included. This will be clinician defined.Stool:1.Adults (age 18 – 75 years).2.Be able to provide written (signed) informed consent.3.Be willing and able to comply with routine clinic visits and study-related procedures.4.Be able to understand and complete study-related questionnaires.5.Liver disease populations: participants must have an established diagnosis of any of the following conditions: 5.1.PSC5.2.PBC5.3.MASLD6.IBD populations: participants must have an established diagnosis of one of the following, without a concurrent diagnosis of PSC:6.1.Ulcerative colitis (UC) 6.2.Crohn’s disease with colonic involvement 6.3.IBD unclassified with colonic involvement7.Healthy control populations: defined as participants who do not have present or previous gastrointestinal or liver disease. Participants with functional gastrointestinal disorder (FGID) can be included. This will be clinician defined.Colonic biopsies:1.Adults (age 18 – 75 years).2.Be able to provide written (signed) informed consent.3.Be willing and able to comply with routine clinic visits and study-related procedures.4.Be able to understand and complete study-related questionnaires.5.Liver disease populations: participants must have an established diagnosis of PSC.6.IBD population: participants must have an established diagnosis of one of the following, without a concurrent diagnosis of PSC:6.1.Ulcerative colitis (UC) 6.2.Crohn’s disease with colonic involvement 6.3.IBD unclassified with colonic involvement7.Healthy control populations:7.1.Participants without a diagnosis of PSC or IBD, attending for a colonoscopy who do not meet the exclusion criteria.Biliary aspirates/biopsies:1.Adults (age 18 – 75 years).2.Be able to provide written (signed) informed consent.3.Be willing and able to comply with routine clinic visits and study-related procedures.4.Be able to understand and complete study-related questionnaires.5.Established diagnosis of PSC.
排除标准
- •Here is the revised text with the requested numbering system:Eligible participants must fulfill the criteria set out below, as related to the sample type in question.Peripheral blood:
- •Liver transplant recipients.
- •Evidence of acute or chronic liver disease not listed in the inclusion criteria, including, but not limited to: 1.
- •Secondary sclerosing cholangitis 1.
- •IgG4-related cholangitis 1.
- •Viral hepatitis 1.
- •Alcohol-related liver disease 1.
- •Drug-induced liver disease or drug-induced sclerosing cholangitis 1.
- •Hereditary haemochromatosis 1.
- •Alpha-1-antitrypsin disease 1.
- •Wilson disease 1.
- •Budd-Chiari Syndrome *Individuals with autoimmune hepatitis, concomitant IBD, and overlapping features of sclerosing cholangitis are eligible and may be recruited to the PSC group.*
- •Evidence of acute or chronic gastrointestinal disease not listed in the inclusion criteria.
- •A history of malignancy within the prior 3 years, except for individuals with: 1.
- •Prior gallbladder cancer, with gallbladder removal, and without evidence of recurrence or disseminated/metastatic disease. 1.
- •Prior colonic cancer, with local resection, and without evidence of recurrence or disseminated/metastatic disease. 1.
- •Prior non-melanomatous skin cancer that has been resected, without evidence of recurrence or disseminated/metastatic disease.
- •If the potential participant is a member of the clinical site study team and/or his/her immediate family.
- •Women who are pregnant or less than 12 weeks post-partum.Stool:
- •Liver transplant recipients.
- •Evidence of acute or chronic liver disease not listed in the inclusion criteria, including, but not limited to: 1.
- •Secondary sclerosing cholangitis 1.
- •IgG4-related cholangitis 1.
- •Viral hepatitis 1.
- •Alcohol-related liver disease 1.
- •Drug-induced liver disease or drug-induced sclerosing cholangitis 1.
- •Hereditary haemochromatosis 1.
- •Alpha-1-antitrypsin disease 1.
- •Wilson disease 1.
- •Budd-Chiari Syndrome *Individuals with autoimmune hepatitis, concomitant IBD, and overlapping features of sclerosing cholangitis are eligible and may be recruited to the PSC group.*
- •Evidence of acute or chronic gastrointestinal disease not listed in the inclusion criteria.
- •A history of malignancy within the prior 3 years, except for individuals with: 1.
- •Prior gallbladder cancer, with gallbladder removal, without evidence of recurrence or disseminated/metastatic disease. 1.
- •Prior colonic cancer, with local resection, without evidence of recurrence or disseminated/metastatic disease. 1.
- •Prior non-melanomatous skin cancer that has been resected, without evidence of recurrence or disseminated/metastatic disease.
- •Previous colonic or small bowel resection.
- •If the potential participant is a member of the clinical site study team and/or his/her immediate family.
- •Women who are pregnant or less than 12 weeks post-partum.Colonic biopsies:
- •Liver transplant recipients.
- •Evidence of acute or chronic liver disease not listed in the inclusion criteria, including, but not limited to: 1.
- •Secondary sclerosing cholangitis 1.
- •IgG4-related cholangitis 1.
- •Viral hepatitis 1.
- •Alcohol-related liver disease 1.
- •Drug-induced liver disease or drug-induced sclerosing cholangitis 1.
- •Hereditary haemochromatosis 1.
- •Alpha-1-antitrypsin diseas
研究者
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