Study of Factors and Mechanisms Influencing the Effects of Treatments in Crohn's Disease
1 other identifier
observational
500
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 2, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedSeptember 2, 2022
January 1, 2022
3.5 years
October 2, 2019
August 30, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
side effects of medications
1 month to 1 year
Study Arms (1)
CD group
no interventions
Interventions
Eligibility Criteria
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.
You may qualify if:
- Newly diagnosed or Previously diagnosed of Crohn's disease according to 2010 WGO criteria for Crohn's disease
- Aged 14-80 years old.
You may not qualify if:
- History of malignancy
- Pregnant/breastfeeding at screening
- Other serious medical or psychiatric illness.
- Unable to comply with protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Chongqing Hospital of the University of Chinese Academy of Sciences (Chongqing People's Hospital)
Chongqing, Chongqing Municipality, China
Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, 310000, China
Huadong Hospital affiliated to Fudan University
Shanghai, China
Biospecimen
Peripheral Blood Mononuclear Cell(PBMCs) were collected from patients and volunteers using Ficoll-PaqueTM PLUS medium (GE Healthcare, Uppsala, Sweden), and total RNA was extracted using TRIzol reagent (Ambion, Carlsbad, CA).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2019
First Posted
October 22, 2019
Study Start
July 1, 2019
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
September 2, 2022
Record last verified: 2022-01