Study of Factors and Mechanisms Influencing the Effects of Treatments in Crohn's Disease

NCT ID: NCT04135027

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-12-30

Brief Summary

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The course of Crohn's disease (CD) varies considerably between patients, but reliable prognostic markers are not available in clinical practice. Even though several parameters have been associated with prognosis in CD-including clinical features, serology and genetic variants-none are sufficient to guide therapy in clinical practice. Trying to find out the mechanisms influencing the effectiveness of treatments and develop a personalized therapy is an urgent problem in the era of biologics as the investigators now have a growing armamentarium of IBD therapies. Several scientists found that the levels of T cells subsets ratio and inflammation cytokines were significantly increased in the intestinal mucosa and serum in active IBD patients, whereas mucosal innate lymph cells had specific effects in inflammation. However the studies about the differences of lymph cell levels between subgroups of IBD patients and their relationships with effectiveness of treatments are relatively rare. Based on above, the investigators plan to recruit patients diagnosed and suspicious of Crohn's disease and a group of diseases in differential diagnosis of CD to keep track of their disease characteristics, therapy and response, collect their blood sample at specific points of time, to investigate the mechanisms of heterogeneity of therapy effectiveness.

Detailed Description

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Conditions

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Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CD group

no interventions

no interventions

Intervention Type OTHER

no interventions

Interventions

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no interventions

no interventions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed or Previously diagnosed of Crohn's disease according to 2010 WGO criteria for Crohn's disease
* Aged 14-80 years old.

Exclusion Criteria

* History of malignancy
* Pregnant/breastfeeding at screening
* Other serious medical or psychiatric illness.
* Unable to comply with protocol requirements
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Chongqing Hospital of the University of Chinese Academy of Sciences (Chongqing People's Hospital)

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status RECRUITING

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Huadong Hospital affiliated to Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Chen, MD

Role: CONTACT

+8613757118653

Wen Hu, MD

Role: CONTACT

+8613819105384

Facility Contacts

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Hong Guo

Role: primary

Xiaoqi Zhang

Role: primary

Wen Hu, MD

Role: primary

Yuanwen Chen

Role: primary

Other Identifiers

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IR2019001055

Identifier Type: -

Identifier Source: org_study_id

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