Inflammatory Bowel DiseasesNCT03266471
Cytokines and Genes in Therapeutic Response in Crohn's Disease
An observational study of Inflammatory Bowel Diseases, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Baseline blood sample, Baseline intestinal biopsies and Crohn's disease activity index (CDAI)
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Oct 2017to 3 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Inflammatory Bowel Disease Clinic, Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, 37232
About this study
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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Baseline blood sample, Baseline intestinal biopsies, Crohn's disease activity index (CDAI), Post treatment blood sample, Post treatment intestinal biopsies
- Keywords
- Cytokines, Pharmacogenetics
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline blood sampleDiagnostic test
Blood sample for cytokine measurements and genetics.
Baseline intestinal biopsiesDiagnostic test
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)Other
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 sampleDiagnostic test
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 biopsiesDiagnostic test
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 sampleDiagnostic test
Stool sample for inflammatory markers or microbiome analysis.
Post treatment stool sampleDiagnostic test
Stool sample for inflammatory markers or microbiome analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Baseline blood sample; Diagnostic Test: Baseline intestinal biopsies; Other: Crohn's disease activity index (CDAI); Diagnostic Test: Post treatment blood sample; Diagnostic Test: Post treatment intestinal biopsies; Diagnostic Test: Baseline stool sample; Diagnostic Test: Post treatment stool sample | |
| 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. Receives: Diagnostic Test: Baseline blood sample; Diagnostic Test: Baseline intestinal biopsies; Diagnostic Test: Baseline stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (2)
Compare serum and tissue pro-inflammatory cytokines in CD patients and healthy subjects.
The investigators will compare serum and tissue cytokine/chemokine levels to see if Crohn's disease patients express a difference versus control.
Measured: 26 weeks
To assess whether gene variants are associated with treatment response.
The investigators will collect a one time whole blood sample from subjects starting a new anti-cytokine agent (infliximab, infliximab biosimilar, adalimumab, certolizumab, ustekinumab, or vedolizumab) and extract DNA and genotype. The investigators will look for associations between genotype and treatment response.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start13 Oct 2017
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Scoville, Vanderbilt University Medical Center
- Investigators
- Elizabeth Scoville, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266471
- Sponsor's protocol ID
- 171198
- Status last verified
- May 2022
- First submitted
- 28 Aug 2017
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokines and Genes in Therapeutic Response in Crohn's Disease
- ClinicalTrials.gov ID
- NCT03266471
- Acronym / sponsor ID
- 171198
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Cytokines, Pharmacogenetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease Patients | – | Diagnostic Test: Baseline blood sample, Diagnostic Test: Baseline intestinal biopsies, Other: Crohn's disease activity index (CDAI), Diagnostic Test: Post treatment blood sample, Diagnostic Test: Post treatment intestinal biopsies, Diagnostic Test: Baseline stool sample, Diagnostic Test: Post treatment stool samplePatients 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 | – | Diagnostic Test: Baseline blood sample, Diagnostic Test: Baseline intestinal biopsies, Diagnostic Test: Baseline stool sampleHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline blood sampleBlood sample for cytokine measurements and genetics. | Diagnostic test | Controls, Crohn's disease Patients |
| Baseline intestinal biopsiesUp 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. | Diagnostic test | Controls, Crohn's disease Patients |
| 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. | Other | Crohn's disease Patients |
| Post treatment blood sampleBlood sample for cytokine measurements after patients have been on therapy for at least 6 weeks but no more than 52 weeks. | Diagnostic test | Crohn's disease Patients |
| Post treatment intestinal biopsiesUp 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. | Diagnostic test | Crohn's disease Patients |
| Baseline stool sampleStool sample for inflammatory markers or microbiome analysis. | Diagnostic test | Controls, Crohn's disease Patients |
| Post treatment stool sampleStool sample for inflammatory markers or microbiome analysis. | Diagnostic test | Crohn's disease Patients |
Primary outcome
Compare longitudinal cytokine measurements in treatment responders versus nonresponders.
Time frame: 52 weeks
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.
2 secondary outcomes
Compare serum and tissue pro-inflammatory cytokines in CD patients and healthy subjects.
Time frame: 26 weeks
To assess whether gene variants are associated with treatment response.
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Scoville, MD principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Vanderbilt University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare longitudinal cytokine measurements in treatment responders versus nonresponders. (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.