ArticleBMJ open2018
PRedicting Outcomes For Crohn's dIsease using a moLecular biomarkEr (PROFILE): protocol for a multicentre, randomised, biomarker-stratified trial.
Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Prognostic tools for identification of high risk in people with Crohn's disease: systematic review and cost-effectiveness study.Health technology assessment (Winchester, England) · 2021Pooled it
- Predicting outcomes for Crohn's disease using a molecular biomarker: profile trial.Clinical medicine (London, England) · 2022Trial
- Recent advances in the management of small bowel Crohn's disease.The Korean journal of internal medicine · 2026Review
- Epigenetic biomarkers in inflammatory bowel diseases-computational challenges and opportunities.Journal of Crohn's & colitis · 2026Review
- Advances in Crohn's Disease: A Comprehensive Review of Pathophysiology, Diagnosis, and Emerging Therapeutics.JGH open : an open access journal of gastroenterology and hepatology · 2026Review
- Anti-tumor necrosis factor treatment from diagnosis is more effective and less costly than conventional "step-up" care for patients with active Crohn's disease: a cost-effectiveness analysis from the PROFILE trial.Journal of Crohn's & colitis · 2025Article
- The current state of imaging biomarker development and evaluation.The British journal of radiology · 2025Review
- Recent trends in gene-targeted therapies and their influence on surgical decision-making in rheumatoid arthritis affecting the hands, feet, and ankles.Frontiers in medicine · 2025Review
- Biomarkers That Predict Crohn's Disease Outcomes.Journal of the Canadian Association of Gastroenterology · 2024Review
- Biomarkers in inflammatory bowel disease: a practical guide.Therapeutic advances in gastroenterology · 2024Review
- Integration and implementation of precision medicine in the multifaceted inflammatory bowel disease.World journal of gastroenterology · 2023Review
- Are We Ready to Reclassify Crohn's Disease Using Molecular Classification?Journal of clinical medicine · 2023Article
- Precision Medicine in Inflammatory Bowel Disease.Diagnostics (Basel, Switzerland) · 2023Review
- Recent Advances and Potential Multi-Omics Approaches in the Early Phases of Inflammatory Bowel Disease.Journal of clinical medicine · 2023Review
- Harnessing the Power of Precision Medicine and Novel Biomarkers to Treat Crohn's Disease.Journal of clinical medicine · 2023Review
- Anti-Integrin αvβ6 Autoantibodies Are a Novel Biomarker That Antedate Ulcerative Colitis.Gastroenterology · 2023Article
- Precision medicine in inflammatory bowel disease: Individualizing the use of biologics and small molecule therapies.World journal of gastroenterology · 2023Review
- Characterisation of the Circulating Transcriptomic Landscape in Inflammatory Bowel Disease Provides Evidence for Dysregulation of Multiple Transcription Factors Including NFE2, SPI1, CEBPB, and IRF2.Journal of Crohn's & colitis · 2022Article
- Early Diagnosis, Early Stratification, and Early Intervention to Deliver Precision Medicine in IBD.Inflammatory bowel diseases · 2022Review
- The Future of Precision Medicine to Predict Outcomes and Control Tissue Remodeling in Inflammatory Bowel Disease.Gastroenterology · 2022Review
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
backgroundThe course of Crohn's disease (CD) varies substantially between individuals, but reliable prognostic markers do not exist. This hinders disease management because patients with aggressive disease are undertreated by conventional 'step-up' therapy (in which treatment is gradually escalated in response to refractory or relapsing disease) while those with more indolent disease would be exposed to unnecessary treatment-related toxicity if a more aggressive 'top-down' approach was indiscriminately used. The Predicting outcomes for Crohn's disease using a molecular biomarker trial will assess whether a prognostic transcriptional biomarker, that we have developed and validated, can improve clinical outcomes by facilitating personalised therapy in CD. This represents the first the biomarker-stratified trial in inflammatory bowel disease. METHODS AND ANALYSIS: This biomarker-stratified trial will compare the relative efficacy of 'top-down' and 'accelerated step-up' therapy between biomarker-defined subgroups of patients with newly diagnosed CD. 400 participants from ~50 UK centres will be recruited. Subjects within each biomarker subgroup (IBD ETHICS AND DISSEMINATION: Ethical approval has been obtained and recruitment is under way at sites around the UK. Following trial completion and data analysis, the results of the trial will be submitted for publication in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: ISRCTN11808228; Pre-results.
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