IBDIBDSLNCT02130349
IBDSL Biobank Project. Molecular Markers for Diagnosis and Therapy Response in IBD.
An observational study of IBD and Crohns Disease, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial summary
The IBD South Limburg (IBDSL) project was initially designed as a prospective population based cohort study. Since 1991, all new IBD cases have been enrolled in the cohort and prospectively followed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBD, Crohns Disease, Ulcerative Colitis
- How many people
- 5,000 participants
- Where
- 3 sitesNetherlands
- Study dates
- Feb 2011to Dec 2020
- How long will I take part?
- 25 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult IBD patients (>18 years) residing permanently in South Limburg are eligible. IBD was diagnosed by certified gastroenterologists according to the Lennard-Jones criteria, and was proven by endoscopic and/or radiologic evidence and by histologic evidence. To capture the full South Limburg IBD population, a multifaceted approach was used. Incident cases were prospectively identified through the three hospitals. Missed patients were retrospectively identified using PALGA, the nationwide histopathology registry containing data on all endoscopic biopsies.
Who may be able to join
- All adult IBD patients (>18 years) residing permanently in South Limburg are eligible. IBD was diagnosed by certified gastroenterologists according to the Lennard-Jones criteria, and was proven by endoscopic and/or radiologic evidence and by histologic evidence.
Who cannot join
- <18 years,
Trial locations and contacts
3 sites in 1 country.
Marieke Pierik, PhD, MD contact
Netherlands3 sites, 3 recruiting
- Recruiting
Atrium Medical Centre
Heerlen, Limburg
Liekele Oostenbrug, PhD, MD, l.oostenbrug@atriummc.nl
- Recruiting
Maastricht University medical Center
Maastricht, Limburg
Marieke Pierik, PhD, MD, m.pierik@mumc.nl
- Recruiting
Orbis Medical Centre
Sittard, Limburg
Marielle Romberg-Camps, PhD, MD, m.camps@orbisconcern.nl
About this study
Official title: IBDSL Biobank Project. Molecular Markers for Diagnosis and Therapy Response in IBD. A Prospective Population Based Biobank of Inflammatory Bowel Disease Patients in Zuid Limburg, The Netherlands.
The IBD South Limburg (IBDSL) project was initially designed as a prospective population based cohort study. Since 1991, all new IBD cases have been enrolled in the cohort and prospectively followed. As from 2011, the cohort is being scaled up into a population based biobank and focus expanded from epidemiology towards exploring underlying biologic mechanisms and identifying markers to predict disease course or therapy response.
Every adult IBD patient, diagnosed in and permanently residing in South Limburg (The Netherlands), is eligible to participate. The population based nature was reached via a multi-faceted approach; incident cases were prospectively identified through the participating hospitals, and missed patients were retrospectively identified using the nationwide histopathology registry. In 2011, over 3500 patients were included, which represents 93% of the IBD population in South Limburg.
Read more
The cohort includes baseline data, such as IBD phenotype, extent, location, behaviour, extra intestinal manifestations, medication, surgery, comorbidity and demographics. Data has prospectively been updated through chart review (clinical data), questionnaires (i.e. quality of life) and linkage to the authority database (vital state, residence). The biobank includes serum, plasma, DNA, faeces, biopsies and exhaled air.
We welcome new collaborations. Applications for collaboration are first to be approved by our IBD-SL committee.
Read the detailed description
Background: Inflammatory Bowel Disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic disabling condition of the intestine. Most patients experience sequences of exacerbation in which quality of life is often impaired. Also society endures heavily, as IBD healthcare costs are estimated at 4.6-5.6 billion euros per year and high rates of unemployment and work disability are reported. The current incidence estimate is 256.000 Europeans per year, and yet increases.
IBD arises from complex interactions between a genetically altered intestinal immune response, environmental factors and intestinal microbiota. Disease phenotypes are heterogeneous and predicting individual disease course or therapy response is still merely possible; treatment of choice for instance remains a trial-and-error based succession of regimens. Further exploration of the underlying biologic mechanisms, and the identification and validation of non-invasive markers to predict disease course and therapy response are the foremost challenges in IBD field at this moment.
Deeply phenotyped IBD cohorts with a biobank are ideal tools for this type of research, and are warranted. Most IBD biobanks reflect hospital based populations thereby over representing severe and therapy refractory patients. However, many hypotheses require designs with a full IBD spectrum. Secondly, phenotypes are mostly ascertained retrospectively, which makes results prone for bias. As no prospective population based biobank excists, we started the population based IBD South Limburg (IBDSL) biobank project.
IBDSL: The IBDSL project was first established in 1991, when gastroenterologists started prospectively registering all IBD patients residing in South Limburg, the Netherlands. As from 2011, this cohort is being scaled up into a biobank and focus expanded from epidemiology towards exploring underlying biologic mechanisms and identifying markers to predict disease course or therapy response.
Population: Every adult IBD patient, diagnosed in South Limburg after 1991 and permanently residing in South Limburg (the Netherlands), is eligible to participate. The population based nature was reached via a multi-faceted approach; incident cases were prospectively identified through the participating hospitals, and missed patients were retrospectively identified using the nationwide histopathology registry. In 2011, over 3500 patients were included, representing >93% of the IBD population in South Limburg. Adults and partners of included patients serve as controls.
Datacollection: All eligible IBD patients will be contacted and asked to participate. Patients will be visited at home or in hospital by a research nurse. After informed consent, DNA, serum, plasma, exhaled air and stool are collected. All data will be added into a custommade web-based data management system (MACRO). All biomaterials are stored in the central biobank facility of the MUMC.
Additional information: IBDSL is a Dutch consortium comprising the gastroenterology departments of Maastricht University Medical Centre+ and the general district hospitals Orbis MC Sittard-Geleen and Atrium MC Heerlen. IBDSL is investigator initiated and has been funded by the consortium members. IBDSL has been approved by the Ethics Committee of the Maastricht University Medical Centre (METC 10-2-071, NL31636.068.10), and meets the ethical standards of the declaration of Helsinki. We welcome new collaborations. Applications for collaboration are first to be approved by our IBD-SL committee.
- Conditions
- IBD, Crohns Disease, Ulcerative Colitis
- Keywords
- IBD, Crohns Disease, Ulcerative Colitis, Cohort, Biobank, Population based, IBDSL
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Crohns Disease | IBD patients diagnosed with Crohn's disease | |
| Ulcerative colitis | IBD patients diagnosed with ulcerative colitis | |
| IBD-Undefined | IBD patients with undefined IBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of seral, fecal, or volatile (exhaled air) biomarkers that reflect disease course and therapy response.
Primary aim of IBDSL: identify/validate markers that predict disease course and therapy response.
Focus lies on all future potent biomarkers (not possible to specify at this timepoint) in blood, dna, faeces, exhaled air and biopsies. Identifying new biomarkers is done by a bolomic approach, in order to find a biomarker(-set) that predict specific aspects of disease course (severe or mild disease course, occurence of extra-intestinal manifestations and/or surgery) and therapy response (chance of therapy success). Validation of already identified biomarkers will be done in a hypothesis driven approach.
Disease course and therapy response are reflected by endoscopic activity, clinical activity scores, number of flares, hospitalisations, surgeries, extra intestinal manifestations, comorbidity. These parameters are monitored at baseline, and at every consequent hospital visit (at least annually) until lost-to-follow-up (death, migration out of region, withdraw).
Measured: Disease course is monitored at baseline, and at every consequent hospital visit (at least annually) until lost-to-follow-up (death, migration out of region, withdraw). Biomaterial is collected at a (non-specified) timepoint after diagnosis.
Secondary outcomes (1)
Epidemiologic parameters
Secondary aim of IBDSL: Periodic analysis of epidemiologic parameters
Epidemiology is reflected by incidence, prevalence, mortality, standardized comorbidic incidence ratios, and (environmental) assocations/risk factors.
Measured: Disease course is monitored at baseline, and at every consequent hospital visit (at least annually) until lost-to-follow-up (death, migration out of region, withdrawal). Epidemiologic parameters are determined annually (since 1991)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startFeb 2011
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Maastricht 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marieke Pierik, PhD, MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130349
- Sponsor's protocol ID
- IBDSL biobank project
- Acronym
- IBDSL
- Status last verified
- Mar 2016
- First submitted
- 24 Apr 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IBDSL Biobank Project. Molecular Markers for Diagnosis and Therapy Response in IBD. A Prospective Population Based Biobank of Inflammatory Bowel Disease Patients in Zuid Limburg, The Netherlands.
- ClinicalTrials.gov ID
- NCT02130349
- Acronym / sponsor ID
- IBDSL / IBDSL biobank project
- Conditions
- IBD, Crohns Disease, Ulcerative Colitis
- Keywords
- IBD, Crohns Disease, Ulcerative Colitis, Cohort, Biobank, Population based, IBDSL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 May 2014 (estimated)
- 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.
The IBD South Limburg (IBDSL) project was initially designed as a prospective population based cohort study. Since 1991, all new IBD cases have been enrolled in the cohort and prospectively followed. As from 2011, the cohort is being scaled up into a population based biobank and focus expanded from epidemiology towards exploring underlying biologic mechanisms and identifying markers to predict disease course or therapy response.
Every adult IBD patient, diagnosed in and permanently residing in South Limburg (The Netherlands), is eligible to participate. The population based nature was reached via a multi-faceted approach; incident cases were prospectively identified through the participating hospitals, and missed patients were retrospectively identified using the nationwide histopathology registry. In 2011, over 3500 patients were included, which represents 93% of the IBD population in South Limburg.
The cohort includes baseline data, such as IBD phenotype, extent, location, behaviour, extra intestinal manifestations, medication, surgery, comorbidity and demographics. Data has prospectively been updated through chart review (clinical data), questionnaires (i.e. quality of life) and linkage to the authority database (vital state, residence). The biobank includes serum, plasma, DNA, faeces, biopsies and exhaled air.
We welcome new collaborations. Applications for collaboration are first to be approved by our IBD-SL committee.
Detailed description
Background: Inflammatory Bowel Disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic disabling condition of the intestine. Most patients experience sequences of exacerbation in which quality of life is often impaired. Also society endures heavily, as IBD healthcare costs are estimated at 4.6-5.6 billion euros per year and high rates of unemployment and work disability are reported. The current incidence estimate is 256.000 Europeans per year, and yet increases.
IBD arises from complex interactions between a genetically altered intestinal immune response, environmental factors and intestinal microbiota. Disease phenotypes are heterogeneous and predicting individual disease course or therapy response is still merely possible; treatment of choice for instance remains a trial-and-error based succession of regimens. Further exploration of the underlying biologic mechanisms, and the identification and validation of non-invasive markers to predict disease course and therapy response are the foremost challenges in IBD field at this moment.
Deeply phenotyped IBD cohorts with a biobank are ideal tools for this type of research, and are warranted. Most IBD biobanks reflect hospital based populations thereby over representing severe and therapy refractory patients. However, many hypotheses require designs with a full IBD spectrum. Secondly, phenotypes are mostly ascertained retrospectively, which makes results prone for bias. As no prospective population based biobank excists, we started the population based IBD South Limburg (IBDSL) biobank project.
IBDSL: The IBDSL project was first established in 1991, when gastroenterologists started prospectively registering all IBD patients residing in South Limburg, the Netherlands. As from 2011, this cohort is being scaled up into a biobank and focus expanded from epidemiology towards exploring underlying biologic mechanisms and identifying markers to predict disease course or therapy response.
Population: Every adult IBD patient, diagnosed in South Limburg after 1991 and permanently residing in South Limburg (the Netherlands), is eligible to participate. The population based nature was reached via a multi-faceted approach; incident cases were prospectively identified through the participating hospitals, and missed patients were retrospectively identified using the nationwide histopathology registry. In 2011, over 3500 patients were included, representing >93% of the IBD population in South Limburg. Adults and partners of included patients serve as controls.
Datacollection: All eligible IBD patients will be contacted and asked to participate. Patients will be visited at home or in hospital by a research nurse. After informed consent, DNA, serum, plasma, exhaled air and stool are collected. All data will be added into a custommade web-based data management system (MACRO). All biomaterials are stored in the central biobank facility of the MUMC.
Additional information: IBDSL is a Dutch consortium comprising the gastroenterology departments of Maastricht University Medical Centre+ and the general district hospitals Orbis MC Sittard-Geleen and Atrium MC Heerlen. IBDSL is investigator initiated and has been funded by the consortium members. IBDSL has been approved by the Ethics Committee of the Maastricht University Medical Centre (METC 10-2-071, NL31636.068.10), and meets the ethical standards of the declaration of Helsinki. We welcome new collaborations. Applications for collaboration are first to be approved by our IBD-SL committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crohns Disease | – | –IBD patients diagnosed with Crohn's disease |
| Ulcerative colitis | – | –IBD patients diagnosed with ulcerative colitis |
| IBD-Undefined | – | –IBD patients with undefined IBD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult IBD patients (>18 years) residing permanently in South Limburg are eligible. IBD was diagnosed by certified gastroenterologists according to the Lennard-Jones criteria, and was proven by endoscopic and/or radiologic evidence and by histologic evidence. To capture the full South Limburg IBD population, a multifaceted approach was used. Incident cases were prospectively identified through the three hospitals. Missed patients were retrospectively identified using PALGA, the nationwide histopathology registry containing data on all endoscopic biopsies.
Key inclusion criteria (1 listed)
- All adult IBD patients (>18 years) residing permanently in South Limburg are eligible. IBD was diagnosed by certified gastroenterologists according to the Lennard-Jones criteria, and was proven by endoscopic and/or radiologic evidence and by histologic evidence.
Key exclusion criteria (1 listed)
- <18 years,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of seral, fecal, or volatile (exhaled air) biomarkers that reflect disease course and therapy response.
Time frame: Disease course is monitored at baseline, and at every consequent hospital visit (at least annually) until lost-to-follow-up (death, migration out of region, withdraw). Biomaterial is collected at a (non-specified) timepoint after diagnosis.
Primary aim of IBDSL: identify/validate markers that predict disease course and therapy response. Focus lies on all future potent biomarkers (not possible to specify at this timepoint) in blood, dna, faeces, exhaled air and biopsies. Identifying new biomarkers is done by a bolomic approach, in order to find a biomarker(-set) that predict specific aspects of disease course (severe or mild disease course, occurence of extra-intestinal manifestations and/or surgery) and therapy response (chance of therapy success). Validation of already identified biomarkers will be done in a hypothesis driven approach. Disease course and therapy response are reflected by endoscopic activity, clinical activity scores, number of flares, hospitalisations, surgeries, extra intestinal manifestations, comorbidity. These parameters are monitored at baseline, and at every consequent hospital visit (at least annually) until lost-to-follow-up (death, migration out of region, withdraw).
1 secondary outcome
Epidemiologic parameters
Time frame: Disease course is monitored at baseline, and at every consequent hospital visit (at least annually) until lost-to-follow-up (death, migration out of region, withdrawal). Epidemiologic parameters are determined annually (since 1991)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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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.
Marieke Pierik, PhD, MD contact
Marieke Pierik, PhD, MD principal investigator
Maastricht University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Crohns Disease, run by Maastricht University Medical Center at 3 sites in Netherlands.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marieke Pierik, PhD, MD (m.pierik@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of seral, fecal, or volatile (exhaled air) biomarkers that reflect disease course and therapy response. (time frame: Disease course is monitored at baseline, and at every consequent hospital visit (at least annually) until lost-to-follow-up (death, migration out of region, withdraw). Biomaterial is collected at a (non-specified) timepoint after diagnosis.). 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 16 Mar 2016.