Cytokines and Genes in Therapeutic Response in Crohn's Disease
NCT ID: NCT03266471
Last Updated: 2023-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
96 participants
OBSERVATIONAL
2017-10-13
2022-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Baseline blood sample
Blood sample for cytokine measurements and genetics.
Baseline intestinal biopsies
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.
Crohn's disease activity index (CDAI)
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.
Post treatment blood sample
Blood sample for cytokine measurements after patients have been on therapy for at least 6 weeks but no more than 52 weeks.
Post treatment intestinal biopsies
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.
Baseline stool sample
Stool sample for inflammatory markers or microbiome analysis.
Post treatment stool sample
Stool sample for inflammatory markers or microbiome analysis.
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.
Baseline blood sample
Blood sample for cytokine measurements and genetics.
Baseline intestinal biopsies
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.
Baseline stool sample
Stool sample for inflammatory markers or microbiome analysis.
Interventions
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Baseline blood sample
Blood sample for cytokine measurements and genetics.
Baseline intestinal biopsies
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.
Crohn's disease activity index (CDAI)
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.
Post treatment blood sample
Blood sample for cytokine measurements after patients have been on therapy for at least 6 weeks but no more than 52 weeks.
Post treatment intestinal biopsies
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.
Baseline stool sample
Stool sample for inflammatory markers or microbiome analysis.
Post treatment stool sample
Stool sample for inflammatory markers or microbiome analysis.
Eligibility Criteria
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Inclusion Criteria
* Healthy adults without IBD undergoing colonoscopy for colorectal cancer screening or other non-IBD related indication.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Elizabeth Scoville
Principal Investigator
Principal Investigators
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Elizabeth Scoville, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Inflammatory Bowel Disease Clinic, Vanderbilt University Medical Center
Nashville, Tennessee, United States
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, United States
Countries
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Other Identifiers
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171198
Identifier Type: -
Identifier Source: org_study_id
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