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临床试验/NCT03756649
NCT03756649Enrolling By Invitation不适用

Mayo Clinic IBD Biobank

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
Mayo Clinic
入组人数
1,000
试验地点
1
主要终点
Study Participants

研究概览

简要总结

Researchers are collecting and storing blood, stool, and urine samples and medical information to better understand Inflammatory Bowel Disease (IBD) to improve disease outcome.

详细描述

Subjects will be sent a letter detailing the proposed biobank and soliciting enrollment. Following the informed consent process, subjects will provide a blood sample (50 ml), urine sample (50 ml), and stool. The blood and urine samples will either be collected at the one of the Mayo Clinic outpatient laboratories or by a mail-out kit. Subjects will be asked to complete a questionnaire and 24-hour food recall questionnaire (completed online).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with inflammatory bowel disease (IBD) who are between the ages of 18 and 85 at time of study enrollment.
  • The diagnosis of IBD will be based on the standard IBD criteria including biochemical and colonoscopy screening.
  • Women with inflammatory bowel disease of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.
  • Patients between the ages of 18 and 85 without history of IBD or colon cancer.

排除标准

  • Patients with known liver disease.
  • Patients unable to provide informed consent.
  • Prisoners and institutionalized individuals.
  • Patients with a history of colorectal cancer.

研究组 & 干预措施

Inflammatory bowel disease (IBD)

Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool

干预措施: Blood Draw (Procedure)

Inflammatory bowel disease (IBD)

Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool

干预措施: Urine Collection (Procedure)

Inflammatory bowel disease (IBD)

Subjects with known inflammatory bowel disease will have samples collected of blood, urine and stool

干预措施: Stool Collection (Procedure)

Control Group

Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool

干预措施: Blood Draw (Procedure)

Control Group

Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool

干预措施: Urine Collection (Procedure)

Control Group

Subjects without inflammatory bowel disease (IBD) will have samples collected of blood, urine and stool

干预措施: Stool Collection (Procedure)

结局指标

主要结局

Study Participants

时间窗: 50 years

Total number of participants in the study

次要结局

  • Urine Collection(50 years)
  • Blood Collection(50 years)
  • Stool Collection(50 years)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Konstantinos N. Lazaridis, M.D.

Principal Investigator

Mayo Clinic

研究点 (1)

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