A Non Interventional Pilot Study on Machine Learning for ILD Detection Based on the Patient Data From Digital Devices in Unresectable Stage III Non-Small Cell Lung Cancer Patients Receiving Durvalumab
NCT ID: NCT04884269
Last Updated: 2024-02-15
Study Results
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Basic Information
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COMPLETED
144 participants
OBSERVATIONAL
2021-08-11
2023-03-03
Brief Summary
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Detailed Description
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Data Source(s): Medical records, wearable devices, and mobile application.
Study Population:Patients treated durvalumab following chemoradiation therapy for stage III unresectable NSCLC in Japan from the June 2021 to June 2022. They must fulfil all of the inclusion /exclusion criteria.
Exposure(s): dulvalumab
Outcome(s): Disease progression, ILD including radiation pneumonitis.
Sample Size Estimations : 150 patients
Statistical Analysis: Continuous variables will be reported as mean, median, standard deviation, IQR, maximum, and minimum. Categorical variables will be summarized as absolute frequency and percentage. Ninety-five percent confidence intervals (CIs) will be presented where appropriate. Time-to event for ILD/Disease progression will be estimated by Kaplan-Meir method. Also, in the process of developing model, data production such as per-patient plots of the physiological data(multivariate time series) and physiological data before and after (in a shorter time-scale) the ILD event per event will be considered.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patient who receives durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy
* Patient whose performance status showed 0 or 1 prior to durvalumab treatment
* Patient who is able and willing to wear the devices daily for up to 6 months as instructed
Exclusion Criteria
* Patient had received prior immunotherapy
* Patient under the interventional clinical studies using unapproved drugs or off-label use of drugs
* Patient who showed ILD (including radiation pneumonitis) of Grade 2 and higher, after consolidated chemoradiation therapy.
* Patient who is judged as not suitable for the study by the study site investigators, in terms of fitting wearable devices, presence of silicone or metallic allergy
20 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Nagoya, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Toyoake, Aichi-ken, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Ōta, Gunma, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Matsusaka, Mie-ken, Japan
Research Site
Natori-shi, Miyagi, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Kurashiki, Okayama-ken, Japan
Research Site
Hirakata, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Hidaka, Saitama, Japan
Research Site
Kitaadachi-gun Ina, Saitama, Japan
Research Site
Sunto-gun Nagaizumi, Shizuoka, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Mitaka, Tokyo, Japan
Research Site
Fukuoka, , Japan
Research Site
Niigata, , Japan
Research Site
Okayama, , Japan
Research Site
Osaka, , Japan
Research Site
Tokushima, , Japan
Research Site
Wakayama, , Japan
Countries
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Related Links
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Other Identifiers
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D4194R00024
Identifier Type: -
Identifier Source: org_study_id
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