Evidence map›Paper›PMID 38754881›Full record

ArticleBMJ open2024

Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease: protocol for the Nordic inception cohort study (NORDTREAT).

Anja Fejrskov, Johannes David Füchtbauer, Lóa G Davíðsdóttir, Jonas Halfvarson, Marte Lie Høivik, Michael Dam Jensen, Joachim Høg Mortensen, Lene Nyholm Nielsen, Martin Rejler, Dirk Repsilber and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05414578 (The Nordic IBD Study Within Personalized Medicine - Diagnosing and Prediction Using Molecular Characterization of Inflammatory Bowel Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05414578 completednot on this map

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

Typeobservational_patient_registrySponsorUniversity of Southern DenmarkRan2022 to 2025Enrolled366ConditionsInflammatory Bowel Diseases (IBD), Crohn Disease (CD), Ulcerative Colitis (UC)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Anja FejrskovDepartment of Medical Gastroenterology, Odense University Hospital, Odense, Denmark anja.fejrskov@rsyd.dk David.Fuchtbauer@rsyd.dk.ORCID 0000-0002-1257-8630
Johannes David FüchtbauerDepartment of Medical Gastroenterology, Odense University Hospital, Odense, Denmark anja.fejrskov@rsyd.dk David.Fuchtbauer@rsyd.dk.ORCID 0000-0002-9591-2963
Lóa G DavíðsdóttirDepartment of Gastroenterology, Landspitali National University Hospital of Iceland, Reykjavik, Iceland.
Jonas HalfvarsonDepartment of Internal Medicine, Örebro University Hospital, Örebro, Region Örebro län, Sweden.
Marte Lie HøivikDepartment of Gastroenterology, Oslo University Hospital, Oslo, Norway.
Michael Dam JensenDepartment of Internal Medicine-Gastroenterology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.
Joachim Høg MortensenGastrointestinal Diseases, Nordic Bioscience A/S, Herlev, Denmark.
Lene Nyholm NielsenResearch Unit of Medical Gastroenterology and Hepatology, Hospital South West Jutland, Esbjerg, Denmark.
Martin RejlerJönköping Academy for Improvement in Health and Welfare, Jönköping University, Jönköping, Sweden.ORCID 0000-0003-3286-2898
Dirk RepsilberSchool of Health and Medical Sciences, Örebro University, Örebro, Sweden.
Johan D SöderholmDepartment of Biomedical and Clinical Sciences, Linköping University, Linköping, Östergötland, Sweden.
Claus AalykkeInternal Medicine and Emergency Department, Odense University Hospital, Svendborg, Denmark.
Vibeke AndersenDepartment of Internal Medicine, Molecular Diagnostics and Clinical Research Unit, Institute of Regional Health Research, University Hospital of Southern Denmark, Aabenraa, Denmark.
Robin ChristensenSection for Biostatistics and Evidence-Based Research, Parker Institute, Frederiksberg, Denmark.
Jens KjeldsenDepartment of Medical Gastroenterology, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-8148-6572

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, can be challenging to diagnose, and treatment outcomes are difficult to predict. In the NORDTREAT cohort study, a Nordic prospective multicentre study, we aim to identify novel molecular biomarkers of diagnostic value by assessing the diagnostic test accuracy (cross-sectionally), as well as the prognostic utility when used as prognostic markers in the long-term (cohort study). In the diagnostic test accuracy study, the primary outcome is a successful diagnosis using one or more novel index tests at baseline compared with the ECCO criteria as the reference standard. The composite outcome of the prognostic utility study is 'severe IBD' within 52 weeks from inclusion, defined as one or more of the following three events: IBD-related surgery, IBD-related hospitalisation or IBD-related death. METHODS AND ANALYSIS: We aim to recruit 800 patients referred on suspicion of IBD to this longitudinal observational study, a collaboration between 11 inclusion sites in Denmark, Iceland, Norway and Sweden. Inclusion will occur from February 2022 until December 2023 with screening and baseline visits for all participants and three outcome visits at weeks 12, 26 and 52 after baseline for IBD-diagnosed patients. Biological material (blood, faeces, biopsies, urine and hair), clinical data and lifestyle information will be collected during these scheduled visits. ETHICS AND DISSEMINATION: This study will explore novel biomarkers to improve diagnostic accuracy and prediction of disease progression, thereby improving medical therapy and the quality of life for patients with IBD.The study is approved by the Ethics Committee (DK: S-20200051, v1.4, 16.10.2021; IS: VSNb2021070006/03.01, NO: 193064; SE: DNR 2021-05090) and the Danish Data Protecting Agency (20/54594). Results will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences. CLINICAL TRIAL REGISTRATION NUMBER: NCT05414578; Pre-results.

Indexed as

BiomarkersInflammatory Bowel DiseasesCrohn DiseaseHumansLongitudinal StudiesMulticenter Studies as TopicPrognosisProspective StudiesResearch DesignScandinavian and Nordic CountriesBiomarkersAdult gastroenterologyEndoscopyGastroenterologyInflammatory bowel diseasePrognosis

Identifiers

PMID38754881
PMCPMC11097809

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.