Completed

NCT Number: NCT04135482

CD Patients Immune Status Evaluation

Using single cell sequencing method to evaluate and compare the immune status of patients with severe CD.

Completed

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Key information

Conditions

Severe Crohn's Diease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hanzhou, Zhejiang, 310003, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1, Patients with severe CD（CDAI>16,SES-CD>19） 2, Patients have no previous any drug therapy targeting CD or just received treatment of 5-ASA - Exclusion Criteria: 1, patients have previous treatment of prednisone, immunosuppressive agents such as azathioprine and biologic agents such as infliximab 2, patients were diagnozed as mild-moderate CD 3, patients have other immune disordered diseases such as SLE, PBC, AIH, PSC, sjogren syndrome, ulcerative colitis, and so on.

Treatment and study plan

colonic tissue biopsy

Other

colonic tissue biospy of patients with severe crohn's disease using colonoscopy

Primary outcomes

single cell analysis of the colonic tissue of patients with severe crohn's disease

Time frame: 1 year

single cell analysis of the colonic tissue of patients with severe crohn's disease: inflammed and non-inflammed area from right colon or the terminal ileum

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Evaluating the Immune Status of Patients With Severe Crohn's Disease Using Single Cell Sequencing

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Oct 22, 2019
Registry last updated: Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.