Personalised, Rational, Efficacy-Driven Cancer Drug Dosing via an Artificial Intelligence SystEm (PRECISE): A Protocol for the PRECISE CURATE.AI Pilot Clinical Trial
Introduction: Oncologists have traditionally administered the maximum tolerated doses of drugs in chemotherapy. However, these toxicity-guided doses may lead to suboptimal efficacy. CURATE.AI is an indication-agnostic, mechanism-independent and efficacy-driven personalised dosing platform that may o...
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| Format: | Article |
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Frontiers Media S.A.
2021-04-01
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| Series: | Frontiers in Digital Health |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fdgth.2021.635524/full |
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| author | Benjamin Kye Jyn Tan Chong Boon Teo Xavier Tadeo Xavier Tadeo Xavier Tadeo Siyu Peng Hazel Pei Lin Soh Sherry De Xuan Du Vilianty Wen Ya Luo Aishwarya Bandla Raghav Sundar Raghav Sundar Raghav Sundar Raghav Sundar Raghav Sundar Dean Ho Dean Ho Dean Ho Dean Ho Dean Ho Theodore Wonpeum Kee Theodore Wonpeum Kee Theodore Wonpeum Kee Agata Blasiak Agata Blasiak Agata Blasiak |
| author_facet | Benjamin Kye Jyn Tan Chong Boon Teo Xavier Tadeo Xavier Tadeo Xavier Tadeo Siyu Peng Hazel Pei Lin Soh Sherry De Xuan Du Vilianty Wen Ya Luo Aishwarya Bandla Raghav Sundar Raghav Sundar Raghav Sundar Raghav Sundar Raghav Sundar Dean Ho Dean Ho Dean Ho Dean Ho Dean Ho Theodore Wonpeum Kee Theodore Wonpeum Kee Theodore Wonpeum Kee Agata Blasiak Agata Blasiak Agata Blasiak |
| author_sort | Benjamin Kye Jyn Tan |
| collection | DOAJ |
| description | Introduction: Oncologists have traditionally administered the maximum tolerated doses of drugs in chemotherapy. However, these toxicity-guided doses may lead to suboptimal efficacy. CURATE.AI is an indication-agnostic, mechanism-independent and efficacy-driven personalised dosing platform that may offer a more optimal solution. While CURATE.AI has already been applied in a variety of clinical settings, there are no prior randomised controlled trials (RCTs) on CURATE.AI-guided chemotherapy dosing for solid tumours. Therefore, we aim to assess the technical and logistical feasibility of a future RCT for CURATE.AI-guided solid tumour chemotherapy dosing. We will also collect exploratory data on efficacy and toxicity, which will inform RCT power calculations.Methods and analysis: This is an open-label, single-arm, two-centre, prospective pilot clinical trial, recruiting adults with metastatic solid tumours and raised baseline tumour marker levels who are planned for palliative-intent, capecitabine-based chemotherapy. As CURATE.AI is a small data platform, it will guide drug dosing for each participant based only on their own tumour marker levels and drug doses as input data. The primary outcome is the proportion of participants in whom CURATE.AI is successfully applied to provide efficacy-driven personalised dosing, as judged based on predefined considerations. Secondary outcomes include the timeliness of dose recommendations, participant and physician adherence to CURATE.AI-recommended doses, and the proportion of clinically significant dose changes. We aim to initially enrol 10 participants from two hospitals in Singapore, perform an interim analysis, and consider either cohort expansion or an RCT. Recruitment began in August 2020. This pilot clinical trial will provide key data for a future RCT of CURATE.AI-guided personalised dosing for precision oncology.Ethics and dissemination: The National Healthcare Group (NHG) Domain Specific Review Board has granted ethical approval for this study (DSRB 2020/00334). We will distribute our findings at scientific conferences and publish them in peer-reviewed journals.Trial registration number: NCT04522284 |
| first_indexed | 2024-12-13T12:48:01Z |
| format | Article |
| id | doaj.art-d61c0ac7ee6745dc80dad48aaab69f89 |
| institution | Directory Open Access Journal |
| issn | 2673-253X |
| language | English |
| last_indexed | 2024-12-13T12:48:01Z |
| publishDate | 2021-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Digital Health |
| spelling | doaj.art-d61c0ac7ee6745dc80dad48aaab69f892022-12-21T23:45:25ZengFrontiers Media S.A.Frontiers in Digital Health2673-253X2021-04-01310.3389/fdgth.2021.635524635524Personalised, Rational, Efficacy-Driven Cancer Drug Dosing via an Artificial Intelligence SystEm (PRECISE): A Protocol for the PRECISE CURATE.AI Pilot Clinical TrialBenjamin Kye Jyn Tan0Chong Boon Teo1Xavier Tadeo2Xavier Tadeo3Xavier Tadeo4Siyu Peng5Hazel Pei Lin Soh6Sherry De Xuan Du7Vilianty Wen Ya Luo8Aishwarya Bandla9Raghav Sundar10Raghav Sundar11Raghav Sundar12Raghav Sundar13Raghav Sundar14Dean Ho15Dean Ho16Dean Ho17Dean Ho18Dean Ho19Theodore Wonpeum Kee20Theodore Wonpeum Kee21Theodore Wonpeum Kee22Agata Blasiak23Agata Blasiak24Agata Blasiak25Yong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeYong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeThe N.1 Institute for Health (N.1), National University of Singapore, Singapore, SingaporeThe Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeDepartment of Biomedical Engineering, NUS Engineering, National University of Singapore, Singapore, SingaporeDepartment of Medicine, National University Health System, Singapore, SingaporeYong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeYong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeHaematology-Oncology Research Group, National University Cancer Institute, Singapore (NCIS), Singapore, SingaporeThe N.1 Institute for Health (N.1), National University of Singapore, Singapore, SingaporeYong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeThe N.1 Institute for Health (N.1), National University of Singapore, Singapore, SingaporeThe Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeHaematology-Oncology Research Group, National University Cancer Institute, Singapore (NCIS), Singapore, SingaporeDepartment of Haematology-Oncology, National University Health System, Singapore, SingaporeThe N.1 Institute for Health (N.1), National University of Singapore, Singapore, SingaporeThe Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeDepartment of Biomedical Engineering, NUS Engineering, National University of Singapore, Singapore, SingaporeDepartment of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeSmart Systems Institute, National University of Singapore, Singapore, SingaporeThe N.1 Institute for Health (N.1), National University of Singapore, Singapore, SingaporeThe Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeDepartment of Biomedical Engineering, NUS Engineering, National University of Singapore, Singapore, SingaporeThe N.1 Institute for Health (N.1), National University of Singapore, Singapore, SingaporeThe Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, SingaporeDepartment of Biomedical Engineering, NUS Engineering, National University of Singapore, Singapore, SingaporeIntroduction: Oncologists have traditionally administered the maximum tolerated doses of drugs in chemotherapy. However, these toxicity-guided doses may lead to suboptimal efficacy. CURATE.AI is an indication-agnostic, mechanism-independent and efficacy-driven personalised dosing platform that may offer a more optimal solution. While CURATE.AI has already been applied in a variety of clinical settings, there are no prior randomised controlled trials (RCTs) on CURATE.AI-guided chemotherapy dosing for solid tumours. Therefore, we aim to assess the technical and logistical feasibility of a future RCT for CURATE.AI-guided solid tumour chemotherapy dosing. We will also collect exploratory data on efficacy and toxicity, which will inform RCT power calculations.Methods and analysis: This is an open-label, single-arm, two-centre, prospective pilot clinical trial, recruiting adults with metastatic solid tumours and raised baseline tumour marker levels who are planned for palliative-intent, capecitabine-based chemotherapy. As CURATE.AI is a small data platform, it will guide drug dosing for each participant based only on their own tumour marker levels and drug doses as input data. The primary outcome is the proportion of participants in whom CURATE.AI is successfully applied to provide efficacy-driven personalised dosing, as judged based on predefined considerations. Secondary outcomes include the timeliness of dose recommendations, participant and physician adherence to CURATE.AI-recommended doses, and the proportion of clinically significant dose changes. We aim to initially enrol 10 participants from two hospitals in Singapore, perform an interim analysis, and consider either cohort expansion or an RCT. Recruitment began in August 2020. This pilot clinical trial will provide key data for a future RCT of CURATE.AI-guided personalised dosing for precision oncology.Ethics and dissemination: The National Healthcare Group (NHG) Domain Specific Review Board has granted ethical approval for this study (DSRB 2020/00334). We will distribute our findings at scientific conferences and publish them in peer-reviewed journals.Trial registration number: NCT04522284https://www.frontiersin.org/articles/10.3389/fdgth.2021.635524/fullclinical decision support systemchemotherapypersonalised medicineclinical trialsartificial intelligenceoncology |
| spellingShingle | Benjamin Kye Jyn Tan Chong Boon Teo Xavier Tadeo Xavier Tadeo Xavier Tadeo Siyu Peng Hazel Pei Lin Soh Sherry De Xuan Du Vilianty Wen Ya Luo Aishwarya Bandla Raghav Sundar Raghav Sundar Raghav Sundar Raghav Sundar Raghav Sundar Dean Ho Dean Ho Dean Ho Dean Ho Dean Ho Theodore Wonpeum Kee Theodore Wonpeum Kee Theodore Wonpeum Kee Agata Blasiak Agata Blasiak Agata Blasiak Personalised, Rational, Efficacy-Driven Cancer Drug Dosing via an Artificial Intelligence SystEm (PRECISE): A Protocol for the PRECISE CURATE.AI Pilot Clinical Trial Frontiers in Digital Health clinical decision support system chemotherapy personalised medicine clinical trials artificial intelligence oncology |
| title | Personalised, Rational, Efficacy-Driven Cancer Drug Dosing via an Artificial Intelligence SystEm (PRECISE): A Protocol for the PRECISE CURATE.AI Pilot Clinical Trial |
| title_full | Personalised, Rational, Efficacy-Driven Cancer Drug Dosing via an Artificial Intelligence SystEm (PRECISE): A Protocol for the PRECISE CURATE.AI Pilot Clinical Trial |
| title_fullStr | Personalised, Rational, Efficacy-Driven Cancer Drug Dosing via an Artificial Intelligence SystEm (PRECISE): A Protocol for the PRECISE CURATE.AI Pilot Clinical Trial |
| title_full_unstemmed | Personalised, Rational, Efficacy-Driven Cancer Drug Dosing via an Artificial Intelligence SystEm (PRECISE): A Protocol for the PRECISE CURATE.AI Pilot Clinical Trial |
| title_short | Personalised, Rational, Efficacy-Driven Cancer Drug Dosing via an Artificial Intelligence SystEm (PRECISE): A Protocol for the PRECISE CURATE.AI Pilot Clinical Trial |
| title_sort | personalised rational efficacy driven cancer drug dosing via an artificial intelligence system precise a protocol for the precise curate ai pilot clinical trial |
| topic | clinical decision support system chemotherapy personalised medicine clinical trials artificial intelligence oncology |
| url | https://www.frontiersin.org/articles/10.3389/fdgth.2021.635524/full |
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