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

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))

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Other: no interventions

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Yan Chen, MD; Phone Number: +8613757118653; Email: 1254499542@qq.com
• Study Contact Backup: Name: Wen Hu, MD; Phone Number: +8613819105384; Email: huwen_mc@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Huadong Hospital affiliated to Fudan University
    • Contact: Yuanwen Chen
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • The Chongqing Hospital of the University of Chinese Academy of Sciences (Chongqing People's Hospital)
      • Contact: Hong Guo
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School
      • Contact: Xiaoqi Zhang
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine
      • Contact: Wen Hu, MD; Email: huwen_mc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients aged 14-80 years old, newly diagnosed or previously diagnosed of Crohn's disease according to 2010 WGO criteria for Crohn's disease were recruited from a specialist IBD clinic.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CD group; no interventions	Other: no interventions; no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first treatment escalation	time to first treatment escalation	6 months to 1 year
bowel surgery	time to receive bowel surgery after diagnosis	1 month to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects of medications	side effects of medications including infection and malignancy etc.	1 month to 1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: IR2019001055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No