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

Crohn Disease Clinical Trial

Official title:

Study of Factors and Mechanisms Influencing the Effects of Treatments in Crohn's Disease Patients (a Prospective, Observational Cohort Designed for Precise Evaluation, Personalized RIsk Stratification and Targeted Treatment (PRIST Cohort))

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135027
• Other study ID #: IR2019001055
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yan Chen, MD
• Phone: +8613757118653
• Email: 1254499542[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• no interventions
no interventions

Locations

Country	Name	City	State
China	The Chongqing Hospital of the University of Chinese Academy of Sciences (Chongqing People's Hospital)	Chongqing	Chongqing
China	2nd Affiliated Hospital, School of Medicine	Hangzhou	Zhejiang
China	Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Huadong Hospital affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first treatment escalation	time to first treatment escalation	6 months to 1 year
Primary	bowel surgery	time to receive bowel surgery after diagnosis	1 month to 1 year
Secondary	side effects of medications	side effects of medications including infection and malignancy etc.	1 month to 1 year