Inflammatory Bowel Diseasesi-BANKNCT03809728
IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE
A study testing endoscopic biopsy, samples of the oral cavity and Samples of the resected specimen in people with Inflammatory Bowel Diseases and Crohn Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- endoscopic biopsy, samples of the oral cavity and Samples of the resected specimen
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2019to 10 Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age>=18 years
- Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
- Patients >=45 kg
- Affiliated member of the Social Security system
Who cannot join
- Patients with an undetermined colitis
- Patients with a non established diagnosis of CD
- Women of childbearing age without a method of contraception
- Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
- Pregnant women, breastfeeding women
- -- Age < 18 years
Show all 9Show fewer
- Persons under legal protection
- Person who does not have the capacity to consent
- Persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles L. 3212-1 and L. 3213-1).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, 54510
Marine BECK, +33383155280, m.beck@chru-nancy.fr
Laurent PEYRIN-BIROULET, MD, PhD
About this study
Official title: IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK
Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.
Read the detailed description
Percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-TNF, ustekinumab, vedolizumab).
Response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (MRI), and / or biological (CRP, fecal calprotectin) .
Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).
- Being tested
- endoscopic biopsy, samples of the oral cavity, Samples of the resected specimen
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic biopsyProcedure or surgery
Per-endoscopic biopsies
samples of the oral cavityProcedure or surgery
7 samples of the oral cavity with a swab
Samples of the resected specimenProcedure or surgery
if patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Other | All patients with an established Crohn's disease or ulcerative colitis Receives: Procedure: endoscopic biopsy; Procedure: samples of the oral cavity; Procedure: Samples of the resected specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).
Measured: 5 years
Secondary outcomes (6)
Proportion of patients who underwent surgery
Measured: 5 years
Post-operative morbidity rates in IBD
Measured: 5 years
Surgical recurrent rate in Crohn's disease
Measured: 5 years
Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula)
Measured: 5 years
Proportion of patients developing a cancer
Measured: 5 years
Readmission rates for acute severe colitis or ileitis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start10 Dec 2019
- Primary completion10 Dec 2034 (estimated)
- Study completion10 Dec 2034 (estimated)
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 Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Laurent PEYRIN-BIROULET, Central Hospital, Nancy, France
- Investigators
- Adeline GERMAIN, MD, PhD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809728
- Sponsor's protocol ID
- PSS 2018 / I-BANK-GERMAIN / MS
- Acronym
- i-BANK
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK
- ClinicalTrials.gov ID
- NCT03809728
- Acronym / sponsor ID
- i-BANK / PSS 2018 / I-BANK-GERMAIN / MS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Dec 2034 (estimated)
- Study completion
- 10 Dec 2034 (estimated)
- First posted
- 18 Jan 2019 (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.
Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.
Detailed description
Percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-TNF, ustekinumab, vedolizumab).
Response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (MRI), and / or biological (CRP, fecal calprotectin) .
Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients | Other | Procedure: endoscopic biopsy, Procedure: samples of the oral cavity, Procedure: Samples of the resected specimenAll patients with an established Crohn's disease or ulcerative colitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>=18 years
- Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
- Patients >=45 kg
- Affiliated member of the Social Security system
Key exclusion criteria (9 listed)
- Patients with an undetermined colitis
- Patients with a non established diagnosis of CD
- Women of childbearing age without a method of contraception
- Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
- Pregnant women, breastfeeding women
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 |
|---|---|---|
| endoscopic biopsyPer-endoscopic biopsies | Procedure or surgery | IBD patients |
| samples of the oral cavity7 samples of the oral cavity with a swab | Procedure or surgery | IBD patients |
| Samples of the resected specimenif patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised | Procedure or surgery | IBD patients |
Primary outcome
Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).
Time frame: 5 years
6 secondary outcomes
Proportion of patients who underwent surgery
Time frame: 5 years
Post-operative morbidity rates in IBD
Time frame: 5 years
Surgical recurrent rate in Crohn's disease
Time frame: 5 years
Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula)
Time frame: 5 years
Proportion of patients developing a cancer
Time frame: 5 years
Readmission rates for acute severe colitis or ileitis
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Adeline GERMAIN, MD, PhD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic biopsy, samples of the oral cavity and Samples of the resected specimen in people with Inflammatory Bowel Diseases and Crohn Disease, run by Central Hospital, Nancy, France at 1 site in France.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adeline GERMAIN, MD, PhD (+33383153120, a.germain@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). (time frame: 5 years). 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 7 Feb 2024.