Clinical trial NCT04135027: Study of Factors and Mechanisms Influencing the Effects of Treatments in Crohn's Disease
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))
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: time to first treatment escalation
timeFrame: 6 months to 1 year
measure: bowel surgery
timeFrame: 1 month to 1 year
Secondary outcomes:
measure: side effects of medications
timeFrame: 1 month to 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Chongqing Hospital of the University of Chinese Academy of Sciences (Chongqing People's Hospital)
state: Chongqing
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital (Nanjing Gulou Yi Yuan), the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine
state: Zhejiang
city: Shanghai
country: China
facility: Huadong Hospital affiliated to Fudan University
Study officials:
References: