JPRN-jRCT1051210033Recruiting未知
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 - iDETECT study
Kouda Shigetaka0 sites150 target enrollmentStarted: June 2, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1.Patient who provided written signed informed consent prior to the first study-specific procedures.
- •2.Patient who receives durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy
- •3.Patient whose performance status showed 0 or 1 prior to durvalumab treatment
- •4.Patient aged 20 age old over
- •5.Patient who is able and willing to wear the devices daily for up to 6 months as instructed
Exclusion Criteria
- •1. Patient under immunotherapy treatment other than durvalumab.
- •2. Patient had received prior immunotherapy
- •3. Patient under the interventional clinical studies using unapproved drugs or off-label use of drugs
- •4. Patient who showed ILD (including radiation pneumonitis) of Grade 2 and higher, after consolidated chemoradiation therapy.
- •5.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
Investigators
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