Inclusion of patients with chronic kidney disease in randomized phase 3 clinical trials in patients with prostate, breast, lung, and colorectal cancer
Abstract The objective of this study was to determine the proportion of phase 3 clinical trials investigating a systemic therapy for patients with prostate, breast, lung, or colorectal cancer that excluded patients with Chronic Kidney Disease (CKD) and the exclusion criteria chosen, if any. A search...
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| Format: | Article |
| Language: | English |
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Wiley
2023-02-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.5171 |
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| _version_ | 1850159410080382976 |
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| author | Matthieu Delaye Adrien Rousseau Mélanie Try Christophe Massard Luca Campedel Marc Hilmi Corinne Bagnis |
| author_facet | Matthieu Delaye Adrien Rousseau Mélanie Try Christophe Massard Luca Campedel Marc Hilmi Corinne Bagnis |
| author_sort | Matthieu Delaye |
| collection | DOAJ |
| description | Abstract The objective of this study was to determine the proportion of phase 3 clinical trials investigating a systemic therapy for patients with prostate, breast, lung, or colorectal cancer that excluded patients with Chronic Kidney Disease (CKD) and the exclusion criteria chosen, if any. A search was conducted using the ClinicalTrials.gov database to identify eligible studies. Of the 268 included trials, 185 (69%) had at least one renal exclusion criteria. Of these 185 trials, 116 (63%) had an undefined exclusion criterion. Only disease site was associated with exclusion of patients with CKD in the univariate analysis, but no factors in the multivariate analysis. There are several potential barriers to including patients with CKD in clinical trials. Nevertheless, solutions can be proposed to allow the inclusion of these patients. This would allow them to access to innovative therapeutic strategies, but also allow a better applicability of trial results to this patient population. |
| format | Article |
| id | doaj-art-307fbb4f1f4e4f7a836b0e41278a0e6d |
| institution | OA Journals |
| issn | 2045-7634 |
| language | English |
| publishDate | 2023-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj-art-307fbb4f1f4e4f7a836b0e41278a0e6d2025-08-20T02:23:32ZengWileyCancer Medicine2045-76342023-02-011233172317510.1002/cam4.5171Inclusion of patients with chronic kidney disease in randomized phase 3 clinical trials in patients with prostate, breast, lung, and colorectal cancerMatthieu Delaye0Adrien Rousseau1Mélanie Try2Christophe Massard3Luca Campedel4Marc Hilmi5Corinne Bagnis6Department of Medical Oncology, Institut Curie Versailles Saint‐Quentin University Saint‐Cloud FranceGroupe de Recherche Interdisciplinaire Francophone en Onco‐néphrologie (GRIFON) Paris FranceGroupe de Recherche Interdisciplinaire Francophone en Onco‐néphrologie (GRIFON) Paris FranceDepartment of Medical Oncology, Eugene Marquis Cancer Institute University of Rennes Rennes FranceGroupe de Recherche Interdisciplinaire Francophone en Onco‐néphrologie (GRIFON) Paris FranceDepartment of Medical Oncology, Institut Curie Versailles Saint‐Quentin University Saint‐Cloud FranceGroupe de Recherche Interdisciplinaire Francophone en Onco‐néphrologie (GRIFON) Paris FranceAbstract The objective of this study was to determine the proportion of phase 3 clinical trials investigating a systemic therapy for patients with prostate, breast, lung, or colorectal cancer that excluded patients with Chronic Kidney Disease (CKD) and the exclusion criteria chosen, if any. A search was conducted using the ClinicalTrials.gov database to identify eligible studies. Of the 268 included trials, 185 (69%) had at least one renal exclusion criteria. Of these 185 trials, 116 (63%) had an undefined exclusion criterion. Only disease site was associated with exclusion of patients with CKD in the univariate analysis, but no factors in the multivariate analysis. There are several potential barriers to including patients with CKD in clinical trials. Nevertheless, solutions can be proposed to allow the inclusion of these patients. This would allow them to access to innovative therapeutic strategies, but also allow a better applicability of trial results to this patient population.https://doi.org/10.1002/cam4.5171chronic kidney diseaseenrollmentonco‐nephrologyphase 3 trials |
| spellingShingle | Matthieu Delaye Adrien Rousseau Mélanie Try Christophe Massard Luca Campedel Marc Hilmi Corinne Bagnis Inclusion of patients with chronic kidney disease in randomized phase 3 clinical trials in patients with prostate, breast, lung, and colorectal cancer Cancer Medicine chronic kidney disease enrollment onco‐nephrology phase 3 trials |
| title | Inclusion of patients with chronic kidney disease in randomized phase 3 clinical trials in patients with prostate, breast, lung, and colorectal cancer |
| title_full | Inclusion of patients with chronic kidney disease in randomized phase 3 clinical trials in patients with prostate, breast, lung, and colorectal cancer |
| title_fullStr | Inclusion of patients with chronic kidney disease in randomized phase 3 clinical trials in patients with prostate, breast, lung, and colorectal cancer |
| title_full_unstemmed | Inclusion of patients with chronic kidney disease in randomized phase 3 clinical trials in patients with prostate, breast, lung, and colorectal cancer |
| title_short | Inclusion of patients with chronic kidney disease in randomized phase 3 clinical trials in patients with prostate, breast, lung, and colorectal cancer |
| title_sort | inclusion of patients with chronic kidney disease in randomized phase 3 clinical trials in patients with prostate breast lung and colorectal cancer |
| topic | chronic kidney disease enrollment onco‐nephrology phase 3 trials |
| url | https://doi.org/10.1002/cam4.5171 |
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