The Nordic IBD Study Within Personalized Medicine - Diagnosing and Prediction Using Molecular Characterization of Inflammatory Bowel Disease: the NORDTREAT Prospective Cohort Study

Status: Recruiting
Location: See all (17) locations...
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Referred on the suspicion of inflammatory bowel disease

• Adult (+18 years of age)

• Written informed consent to participate in the study

Locations
Other Locations
Denmark
University Hospital of Southern Denmark
NOT_YET_RECRUITING
Aabenraa
SVS Esbjerg Hospital
NOT_YET_RECRUITING
Esbjerg
Odense University Hospital
RECRUITING
Odense
OUH Svendborg Hospital
RECRUITING
Svendborg
SLB Vejle Hospital
RECRUITING
Vejle
Iceland
Landspitali
RECRUITING
Reykjavik
Norway
Vestre Viken HF
RECRUITING
Drammen
Østfold Kalnes
RECRUITING
Grålum
Oslo Universitetssykehus
RECRUITING
Oslo
Sykehuset i Telemark
RECRUITING
Skien
Sykehuset i Vestfold
RECRUITING
Tønsberg
Sweden
Höglandssjukhuset Eksjö
RECRUITING
Eksjö
Universitetssjukhuset i Linköping
RECRUITING
Linköping
Universitetssjukhuset Örebro
RECRUITING
Örebro
Ersta Sjukhus
RECRUITING
Stockholm
Karolinska Universitetssjukhuset
RECRUITING
Stockholm
Akademiska Sjukhuset Uppsala
RECRUITING
Uppsala
Contact Information
Primary
Vibeke Andersen, Professor
va@rsyd.dk
0045 2115 7790
Time Frame
Start Date: 2022-02-07
Estimated Completion Date: 2031-01
Participants
Target number of participants: 800
Sponsors
Collaborators: University of Oslo, University Hospital of Southern Denmark, Colitis-Crohn Foreningen, University Hospital Bispebjerg and Frederiksberg, Nordic Bioscience A/S, Lovisenberg Diakonale Hospital, Aalborg University, Uppsala University, University of Kiel, Örebro University, Sweden
Leads: University of Southern Denmark

This content was sourced from clinicaltrials.gov