NORDTREAT Prospective Study on Inflammatory Bowel Disease

NCT05414578 | Recruiting

• 1 other identifier: NORDTREAT_MOK 2022
• Study Type: observational
• Target: 800
• Locations: 4 countries
• Sites: 17

Brief Summary

Inflammatory bowel disease (IBD), primarily ulcerative colitis (UC) and Crohn's disease (CD), is a chronic disease entity affecting individuals of all ages, and which may severely impact the lives of the patients and their families as well as society. Individuals with IBD may have to live with relapsing symptoms, such as diarrhea, abdominal pain, and fatigue. Further, a substantial proportion of patients develop serious complications such as bowel obstruction and fistula, and some develop complicating liver disease and eventually colorectal cancer. The consequences are that many patients suffer hospitalizations, recurring sick-leave, life-long medication, and surgical interventions. As IBD has become increasingly common in Western populations there is a clear need to improve the outcome from IBD. IBD is a heterogeneous disease entity with substantial differences between patients and personalized medicine may help provide strategies for better treatment . Currently, one of the main unmet needs is the glaring lack of robust biomarkers for individual disease characterization. This lack leads to delayed diagnosis, worse outcomes, increased mortality and an amplified disease burden. Furthermore, diagnosis of IBD is difficult and early diagnosis is crucial as it helps avoid the development of irreversible organ damage. Therefore, there is an emerging focus on the development of simple, non-invasive, and cheap biomarkers to support clinical decision-making in IBD. This Nordic, prospective, clinical study has the aim of identifying markers that are associated with the diagnosis of IBD and prediction of clinical outcomes with various disease manifestations. Importantly, this study will evaluate the markers in a relevant clinical setting, i.e. among patients referred to the hospital for suspicion on IBD using the ECCO Criteria. Specifically the aims of the study are to:

• Improve the accuracy to diagnose IBD
• Improve the accuracy to define the prognosis of IBD The study is approved by the local Ethics Committee (S-20200051) and the local Data Agency (20/54594).

Conditions

Inflammatory Bowel Diseases (IBD); Crohn Disease (CD); Ulcerative Colitis (UC)

Keywords

Prospective clinical study; Biomarkers; Diagnosis; Prognosis

Outcome Measures

Primary Outcomes (2)

• Improving the accuracy to diagnose IBD

  The primary endpoint in the cross-sectional study will be diagnosis, i.e., IBD (including CD, UC, IBD-U) or non-IBD (patients that are not diagnosed with IBD) at referral. IBD is diagnosed according to the ECCO criteria based on endoscopic, histologic and/or radiological criteria.

  Baseline (Week 0) and Week 52

• Improving the accuracy to define prognosis of IBD

  The primary endpoint in the longitudinal cohort study will be severe IBD at week 52 defined as: * IBD-related surgery or * IBD-related hospitalization (except planned procedures) or * IBD-related death

  Week 52

Secondary Outcomes (18)

• Lack of corticosteroid-free clinical remission at week 12*

  Week 12

• Lack of corticosteroid-free endoscopic healing at week 52*

  Week 52

• Disease impact on patients life (daily functioning and quality of life)

  Week 52

• Disease impact on patients life (perception of health)

  Week 52

• Disease impact on patients life

  Week 52

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the hospital on suspicion of IBD

You may qualify if:

• Referred on the suspicion of inflammatory bowel disease
• Adult (+18 years of age)
• Written informed consent to participate in the study

You may not qualify if:

• A previous known diagnosis of Crohn's disease, ulcerative colitis or IBD-U
• Unable to provide informed consent
• Unable to comply with protocol requirements (e.g., for reasons including alcohol and/or recreational drug abuse)

Sponsors & Collaborators

• University of Southern Denmark: lead
• Nordic Bioscience A/S: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Aalborg University: collaborator
• Colitis-Crohn Foreningen: collaborator
• Uppsala University: collaborator
• Örebro University, Sweden: collaborator
• Lovisenberg Diakonale Hospital: collaborator
• University of Oslo: collaborator
• University of Kiel: collaborator
• University Hospital of Southern Denmark: collaborator

Study Sites (17)

University Hospital of Southern Denmark

Aabenraa, 6200, Denmark

NOT YET RECRUITING

SVS Esbjerg Hospital

Esbjerg, Denmark

NOT YET RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

OUH Svendborg Hospital

Svendborg, Denmark

RECRUITING

SLB Vejle Hospital

Vejle, Denmark

RECRUITING

Landspitali

Reykjavik, 101, Iceland

RECRUITING

Vestre Viken HF

Drammen, 3004, Norway

RECRUITING

Østfold Kalnes

Grålum, 1714, Norway

RECRUITING

Oslo Universitetssykehus

Oslo, 0424, Norway

RECRUITING

Sykehuset i Telemark

Skien, 3710, Norway

RECRUITING

Sykehuset i Vestfold

Tønsberg, 3103, Norway

RECRUITING

Höglandssjukhuset Eksjö

Eksjö, Region Jönköpings Län, 57581, Sweden

RECRUITING

Karolinska Universitetssjukhuset

Stockholm, Region Stockholm, 17176, Sweden

RECRUITING

Akademiska Sjukhuset Uppsala

Uppsala, Region Uppsala, 75185, Sweden

RECRUITING

Universitetssjukhuset i Linköping

Linköping, Region Östergötland, 58185, Sweden

RECRUITING

Ersta Sjukhus

Stockholm, 11691, Sweden

RECRUITING

Universitetssjukhuset Örebro

Örebro, Örebro County, 70185, Sweden

RECRUITING

Related Publications (1)

• Fejrskov A, Fuchtbauer JD, Daviethsdottir LG, Halfvarson J, Hoivik ML, Jensen MD, Mortensen JH, Nielsen LN, Rejler M, Repsilber D, Soderholm JD, Aalykke C, Andersen V, Christensen R, Kjeldsen J. Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease: protocol for the Nordic inception cohort study (NORDTREAT). BMJ Open. 2024 May 15;14(5):e083144. doi: 10.1136/bmjopen-2023-083144.

  PMID: 38754881 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Intestinal biopsies, blood, urine, feces and hair

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Kjeldsen, Professor

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Vibeke Andersen, Professor

  University Hospital of Southern Denmark, Aabenraa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vibeke Andersen, Professor

CONTACT

0045 2115 7790; va@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: June 10, 2022
• Study Start: February 7, 2022
• Primary Completion: January 1, 2024
• Study Completion (Estimated): January 1, 2031
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

IC (1); NO (5); SE (6); DK (5)