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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135027
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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 newly diagnosed and suspicious of Crohn's disease, keep track of their therapy and response, collect their blood sample at specific points of time, to investigate the mechanisms of heterogeneity of therapy effectiveness.

Condition or disease Intervention/treatment
Crohn Disease Other: no interventions

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Factors and Mechanisms Influencing the Effects of Treatments in Crohn's Disease Patients
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
CD group
no interventions
Other: no interventions
no interventions




Primary Outcome Measures :
  1. time to first treatment escalation [ Time Frame: 6 months to 1 year ]
    time to first treatment escalation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients aged 18-80 years old, newly diagnosed or suspicious of Crohn's disease according to WHO criteria for Crohn's disease, who were not receiving concomitant corticosteroids, immunomodulators or biological therapy, were recruited from a specialist IBD clinic. A stable dose of topical or oral 5-ASA was permitted if patients had been diagnosed previously.
Criteria

Inclusion Criteria:

  • Newly diagnosed or suspicious of Crohn's disease according to WHO criteria for Crohn's disease
  • Immunomodulator and anti-TNF naive.
  • Aged 18-80 years old.

Exclusion Criteria:

  • Active malignancy
  • Pregnant/breastfeeding at screening
  • Other serious medical or psychiatric illness.
  • Unable to comply with protocol requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135027


Contacts
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Contact: Yan Chen, MD +8613757118653 1254499542@qq.com
Contact: Wen Hu, MD +8613819105384 huwen_mc@163.com

Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Wen Hu, MD       huwen_mc@163.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04135027    
Other Study ID Numbers: IR2019001055
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases