IBDSL Biobank Project. Molecular Markers for Diagnosis and Therapy Response in IBD.

NCT02130349 | Unknown DMC

• 1 other identifier: IBDSL biobank project
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

IBD; Crohns Disease; Ulcerative Colitis

Keywords

IBD; Crohns Disease; Ulcerative Colitis; Cohort; Biobank; Population based; IBDSL

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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)

Study Arms (3)

Crohns Disease

IBD patients diagnosed with Crohn's disease

Ulcerative colitis

IBD patients diagnosed with ulcerative colitis

IBD-Undefined

IBD patients with undefined IBD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \<18 years,

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (3)

Atrium Medical Centre

Heerlen, Limburg, Netherlands

RECRUITING

Maastricht University medical Center

Maastricht, Limburg, Netherlands

RECRUITING

Orbis Medical Centre

Sittard, Limburg, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA Serum Plasma Stool Exhaled air Biopsies

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Marieke Pierik, PhD, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieke Pierik, PhD, MD

CONTACT

m.pierik@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 5, 2014
• Study Start: February 1, 2011
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

NL (3)