UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043942 |
|---|---|
| Receipt number | R000050167 |
| Scientific Title | Explore research for osimertinib sensitivity in EGFR mutated non-small cell lung cancer; prospective observation study |
| Date of disclosure of the study information | 2021/04/15 |
| Last modified on | 2022/10/15 14:27:47 |
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Basic information
Public title
Explore research for osimertinib sensitivity in EGFR mutated non-small cell lung cancer; prospective observation study
Acronym
Explore research for osimertinib sensitivity in EGFR mutated non-small cell lung cancer; prospective observation study
Scientific Title
Explore research for osimertinib sensitivity in EGFR mutated non-small cell lung cancer; prospective observation study
Scientific Title:Acronym
Explore research for osimertinib sensitivity in EGFR mutated non-small cell lung cancer; prospective observation study
Region
| Japan |
Condition
Condition
EGFR mutated non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore clinical factors that may be candidates for determining susceptibility to osimertinib in EGFR mutated NSCLC patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between treatment response with osimertinib treatment and patients background
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with evaluable disease by RECIST (version 1.1) before osimertinib administration
2) NSCLC patients with EGFR active mutation
3) Patients with formalin-fixed, paraffin-embedded blocks that do not interfere with pathological diagnosis and for whom consent for their use can be obtained from the patient.
Key exclusion criteria
Patients judged as inappropriate by the physician in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Yamada |
Organization
Kyoto Prefectural University of Medicine
Division name
Pulmonary Medicine
Zip code
6028566
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5513
tayamada@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Yoshimura |
Organization
Kyoto Prefectural University of Medicine
Division name
Pulmonary Medicine
Zip code
6028566
Address
465, Kajii-cho, Kamigyo-ku, Kyoto
TEL
0752515513
Homepage URL
aki-y@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
1. Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan
2. Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medicine and Dental Hospital, Niigata, Japan
3. Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan
4. Department of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan
5. Department of Respiratory Medicine, Uji-Tokushukai Medical Center, Kyoto, Japan.
6. Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
7. Department of Medical Oncology, Fukuchiyama City Hospital, Kyoto, Japan.
8. Department of Respiratory Medicine, Otsu City Hospital, Shiga, Japan
9. Department of Respiratory Medicine, Juntendo University, Tokyo, Japan
10. Division of Medical Oncology, Cancer Research Institute, Kanazawa University, Kanazawa, Japan
11. Department of Respiratory Medicine, Fujita Health University School of Medicine, Aichi, Japan
12. Department of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan
13. Department of Thoracic Oncology, Osaka International Cancer Institution, Osaka, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kamigyo-ku, Kyoto,
Tel
075-251-5513
aki-y@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 04 | Month | 15 | Day |
Last modified on
| 2022 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050167
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
