Skip to content

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))

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04135027
Enrollment
500
Registered
2019-10-22
Start date
2019-07-01
Completion date
2022-12-30
Last updated
2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

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.

Interventions

OTHERno interventions

no interventions

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
time to first treatment escalation6 months to 1 yeartime to first treatment escalation
bowel surgery1 month to 1 yeartime to receive bowel surgery after diagnosis

Secondary

MeasureTime frameDescription
side effects of medications1 month to 1 yearside effects of medications including infection and malignancy etc.

Countries

China

Contacts

Primary ContactYan Chen, MD
1254499542@qq.com+8613757118653
Backup ContactWen Hu, MD
huwen_mc@163.com+8613819105384

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026