ArticleCancer medicine2025
Eligibility Criteria in Advanced Urothelial Cancer Clinical Trials: An Assessment of Modernization and Inclusion.
Article in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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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
1 citing paper in PubMed.
- Visualizing Baseline Eligibility Across Locally Advanced or Metastatic Urothelial Cancer Trials and Real-World Cohorts.International journal of urology : official journal of the Japanese Urological Association · 2026Article
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Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIn a joint statement, Friends of Cancer Research and the American Society of Clinical Oncology affirmed the need for broadening clinical trial eligibility criteria to expand patient access to investigational treatments and enroll cohorts more representative of the general population. Our study aimed to characterize and analyze the prevalence of overly exclusionary eligibility criteria in contemporary clinical trials involving patients with locally advanced and metastatic urothelial cancer.
methodsUtilizing MeSH query terms "(metastatic OR advanced OR stage IV OR unresectable) AND (bladder cancer OR upper tract urothelial carcinoma OR upper tract urothelial cancer)" in ClinicalTrials.gov, we identified 205 interventional urothelial cancer trials activated between June 30, 2012 through June 30, 2022. We investigated the prevalence of four potentially restrictive criteria: the presence of brain metastases, HIV infection, hepatitis B/C infection, and the presence of concurrent malignancies. Fisher's Exact test was utilized to ascertain significant associations between criteria and trial characteristics.
resultsOf 205 trials found initially, 37 (18%) contained sufficient data for analysis. Overall, HIV infection and Hepatitis B/C infection were most restrictive, with most trials completely excluding patients with these conditions (89.2%; 56.8%). Restrictiveness for HIV infection and type of therapy were significantly associated, with most exclusionary trials involving combination or immunotherapies (39.4%; 33.3%; p = 0.003). Brain metastases were totally excluded by 35.1% of trials and had 18.9% of trials provide no explicit criteria or guidelines. Most trials specified conditions for the inclusion of patients with concurrent malignancies (91.9%). Variant histology was also underrepresented, with most trials not specifying or totally excluding all variant histology (43.2%; 8.1%).
conclusionHIV infection and hepatitis B/C infection were commonly identified in exclusion criteria across these trials despite limited evidence suggesting these criteria significantly impact therapy efficacy and tolerability. Broadening and modernization of eligibility criteria will ensure more inclusive clinical trials.
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