Cytokines and Genes in Therapeutic Response in Crohn's Disease
1 other identifier
observational
96
1 country
2
Brief Summary
Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis (UC), affects more than 1.6 million people in the United States alone. Though the precise mechanisms underlying the inflammation and immune responses in IBD are still being investigated, various inflammatory mediators, including pro-inflammatory cytokines, and genes have been implicated in the disease process. At present, there are no reliable mechanisms to predict response to individual IBD medications. The investigators seek to evaluate whether inflammatory cytokines change longitudinally during treatment with anti-cytokine agents in both treatment primary responders and primary non-responders. In addition, the investigators will be evaluating the pharmacogenetics of treatment response to these agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Longer than P75 for all trials
2 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
First Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
October 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2022
CompletedApril 14, 2023
May 1, 2022
4.6 years
August 28, 2017
April 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare longitudinal cytokine measurements in treatment responders versus nonresponders.
The investigators will classify Crohn's disease subjects as primary responders or primary non-responders to anti-TNF-α, ustekinumab, or vedolizumab therapy based on clinical, endoscopic, and/or histologic data. The investigators will compare serum and tissue cytokines in CD subjects at before and after treatment initiation.
52 weeks
Secondary Outcomes (2)
Compare serum and tissue pro-inflammatory cytokines in CD patients and healthy subjects.
26 weeks
To assess whether gene variants are associated with treatment response.
52 weeks
Study Arms (2)
Crohn's disease Patients
Patients that are seen in the Inflammatory Bowel Disease clinic with CD confirmed by endoscopy or radiology assessment who are initiating either an anti-tumor necrosis factor (TNF)-α agent (infliximab, adalimumab, certolizumab, or infliximab biosimilar), ustekinumab, or vedolizumab as part of their routine clinical care will be asked to provide blood samples, stool samples, and intestinal biopsies from standard of care colonoscopy at baseline and post therapy of at least 6 weeks duration but not more than 52 weeks.
Controls
Healthy adults without IBD undergoing colonoscopy for colorectal cancer screening or other non-IBD related indication will be asked to provide blood samples, stool samples and intestinal biopsies from standard of care colonoscopy.
Interventions
Blood sample for cytokine measurements and genetics.
Up to 20 additional biopsies will be obtained at the time of standard of care colonoscopy. It is not felt that additional biopsies substantially increases the risk of a colonoscopy. Cytokine measurements will be performed on the tissue collected.
To determine response, a Crohn's Disease Activity Index (CDAI) score will be obtained at time point 1 and time point 2 in all enrolled CD patients. The CDAI is a well validated symptom index for CD which assesses 8 factors including stool frequency, abdominal pain, general well being, CD complications, HCT, and deviation from ideal body weight.
Blood sample for cytokine measurements after patients have been on therapy for at least 6 weeks but no more than 52 weeks.
Up to 20 additional biopsies will be obtained at the time of standard of care colonoscopy at least 6 weeks but no more than 52 weeks after initiation of therapy. It is not felt that additional biopsies substantially increases the risk of a colonoscopy. Cytokine measurements will be performed on the tissue collected.
Stool sample for inflammatory markers or microbiome analysis.
Stool sample for inflammatory markers or microbiome analysis.
Eligibility Criteria
Patients who are scheduled for a colonoscopy at the Vanderbilt Endoscopy Laboratory as part of their routine care and who do not meet any of the pre-defined exclusion criteria will be considered for participation in the study as control subjects. Patients who are part of the Vanderbilt IBD practice who initiate therapy on an anti-TNF, ustekinumab, or vedolizumab as part of their routine care will be considered for participation in the study as subjects.
You may qualify if:
- Patients that are seen in the Inflammatory Bowel Disease clinic with Crohn's disease who are initiating either treatment as part of their routine clinical care.
- Healthy adults without IBD undergoing colonoscopy for colorectal cancer screening or other non-IBD related indication.
You may not qualify if:
- pregnant
- have a known coagulopathy or bleeding disorder
- have known renal or hepatic impairment
- have a history of organ transplantation
- CD patients who are being seen in consultation and do not plan to receive longitudinal care through initiation their new therapy at the Vanderbilt IBD center will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Inflammatory Bowel Disease Clinic, Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, 37232, United States
Biospecimen
Any remaining serum or tissue samples may be evaluated for other markers of IBD or stored for future studies.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Scoville, MD
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 28, 2017
First Posted
August 30, 2017
Study Start
October 13, 2017
Primary Completion
May 3, 2022
Study Completion
May 3, 2022
Last Updated
April 14, 2023
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share