Trial reportGut2021
Naproxen chemoprevention promotes immune activation in Lynch syndrome colorectal mucosa.
Trial report in Gut, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02052908 (A Phase Ib Biomarker Trial of Naproxen in Patients at Risk for DNA Mismatch Repair Deficient Colorectal Cancer), which is not on this map. Cited by 41 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.
A Phase Ib Biomarker Trial of Naproxen in Patients at Risk for DNA Mismatch Repair Deficient Colorectal Cancer
Who cites it
41 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.
- Primary and Secondary Prevention Interventions to Reduce Risk Factors Associated with Colorectal Cancer in High-Risk Groups: a Systematic Literature Review.Journal of cancer education : the official journal of the American Association for Cancer Education · 2023Pooled it
- Exercise Training Reduces the Inflammatory Response and Promotes Intestinal Mucosa-Associated Immunity in Lynch Syndrome.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Trial
- Naproxen chemoprevention induces proliferation of cytotoxic lymphocytes in Lynch Syndrome colorectal mucosa.Frontiers in immunology · 2023Trial
- Exercise therapy in cancer prevention and treatment.Nature reviews. Clinical oncology · 2026Review
- Precision immunotherapy for head and neck cancer: therapeutic combinations, biomarker strategies, and translational challenges.Molecular cancer · 2026Review
- Stage-Dependent Role of Eicosanoids in Colorectal Cancer.International journal of molecular sciences · 2026Article
- Genome-wide CRISPR Screening Reveals a PKA-Driven Resistance Mechanism to Metformin for Oral Cancer Prevention That Can Be Exploited by Combination with NSAIDs.Cancer prevention research (Philadelphia, Pa.) · 2026Article
- Advances in Hereditary Colorectal Cancer: How Precision Medicine Is Changing the Game.Cancers · 2025Review
- Segmental versus Extended Resection for Colon Cancer in Lynch Syndrome.Clinics in colon and rectal surgery · 2025Review
- Antitumor efficacy of intermittent low-dose erlotinib plus sulindac via MHC upregulation and remodeling of the immune cell niche.International journal of cancer · 2025Article
- Inhibition of histone methyltransferase EZH2 for immune interception of colorectal cancer in Lynch syndrome.JCI insight · 2025Article
- Self-Assembling Hydrogels of Naproxen-Conjugated Peptides for Osteoarthritis Treatment.Theranostics · 2025Article
- Uptake of Aspirin Chemoprevention in Patients With Lynch Syndrome.JCO precision oncology · 2024Article
- Analysis of naproxen activation of cell death pathways in Colo320 cells.Molecular and clinical oncology · 2024Article
- Review
- Chemoprevention in Inherited Colorectal Cancer Syndromes.Clinics in colon and rectal surgery · 2024Review
- Current Trends in Vaccine Development for Hereditary Colorectal Cancer Syndromes.Clinics in colon and rectal surgery · 2024Review
- Review
- Review
- Optimizing aspirin dose for colorectal cancer patients through deep phenotyping using novel biomarkers of drug action.Frontiers in pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
32 authors at 8 institutions in 1 country.
Funding
Abstract
objectivePatients with Lynch syndrome (LS) are at markedly increased risk for colorectal cancer. It is being increasingly recognised that the immune system plays an essential role in LS tumour development, thus making an ideal target for cancer prevention. Our objective was to evaluate the safety, assess the activity and discover novel molecular pathways involved in the activity of naproxen as primary and secondary chemoprevention in patients with LS.
designWe conducted a Phase Ib, placebo-controlled, randomised clinical trial of two dose levels of naproxen sodium (440 and 220 mg) administered daily for 6 months to 80 participants with LS, and a co-clinical trial using a genetically engineered mouse model of LS and patient-derived organoids (PDOs).
resultsOverall, the total number of adverse events was not different across treatment arms with excellent tolerance of the intervention. The level of prostaglandin E2 in the colorectal mucosa was significantly decreased after treatment with naproxen when compared with placebo. Naproxen activated different resident immune cell types without any increase in lymphoid cellularity, and changed the expression patterns of the intestinal crypt towards epithelial differentiation and stem cell regulation. Naproxen demonstrated robust chemopreventive activity in a mouse co-clinical trial and gene expression profiles induced by naproxen in humans showed perfect discrimination of mice specimens with LS and PDOs treated with naproxen and control.
conclusionsNaproxen is a promising strategy for immune interception in LS. We have discovered naproxen-induced gene expression profiles for their potential use as predictive biomarkers of drug activity. TRIAL REGISTRATION NUMBER: gov Identifier: NCT02052908.
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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.