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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000031608 |
Receipt No. | R000036081 |
Scientific Title | Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer |
Date of disclosure of the study information | 2018/03/12 |
Last modified on | 2018/08/28 |
Basic information | ||
Public title | Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
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Acronym | Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer | |
Scientific Title | Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
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Scientific Title:Acronym | Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer | |
Region |
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Condition | ||
Condition | non-small cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Early identification of beneficial patients in patients treated with immune checkpoint inhibitors |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The correct rate of decision on 28 days after the start of administration |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1 Histologically or cytologically confirmed non-small cell lung cancer
2 At least one regimen or more of chemotherapy has been performed 3 18 years-old or over 4 Patients were judged appropriate by the attending physician as subjects of immune checkpoint inhibitors 5 Whether or not there is an evaluable lesion is not required 6 Patients who have adequate organ function 7 Patients provided written imformed consent |
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Key exclusion criteria | 1 Patients who the physician judges unsuitable for this study
2 Patients who had pretreatment with immune checkpoint inhibitor |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka Habikino medical center | ||||||
Division name | Department of thoracic oncology | ||||||
Zip code | |||||||
Address | 3-7-1 habikino habikino-city OSAKA | ||||||
TEL | 0729572121 | ||||||
hirashimat@opho.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka Habikino Medical Center | ||||||
Division name | Department of Thoracic oncology | ||||||
Zip code | |||||||
Address | 3-7-1 habikino habikino-city OSAKA | ||||||
TEL | 0729572121 | ||||||
Homepage URL | |||||||
suzukih@opho.jp |
Sponsor | |
Institute | Osaka Habikino Medical Center |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | 大阪はびきの医療センター(大阪府) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | observational study |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036081 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |