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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000033993 |
Receipt No. | R000038757 |
Scientific Title | A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer |
Date of disclosure of the study information | 2018/09/05 |
Last modified on | 2018/09/11 |
Basic information | ||
Public title | A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer | |
Acronym | A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer | |
Scientific Title | A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer | |
Scientific Title:Acronym | A retrospective study to investigate PD-L1 expression before and after EGFR-TKI therapy and its relationship with EGFR-TKI resistance mechanism in EGFR mutation-positive advanced recurrent non- squamous non-small-cell lung cancer | |
Region |
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Condition | ||||
Condition | EGFR mutation-positive advanced recurrent non-squamous non-small-cell lung cancer | |||
Classification by specialty |
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Classification by malignancy | Malignancy | |||
Genomic information | YES |
Objectives | |
Narrative objectives1 | To evaluate changes in tumor immune microenvironment between before and after EGFR-TKI therapy by immunostaining in patients with EGFR mutation-positive advanced recurrent non-squamous non-small-cell lung cancer.
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Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The changes in PD-L1 expression level, CD73, TILs, and nonsynonymous mutation burden before and after EGFR-TKIs treatment |
Key secondary outcomes |
Base | |
Study type | Others,meta-analysis etc |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
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Eligibility | ||||
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Aged 20 years or older
2)Patients with pathologically confirmed non-squamous non-small-cell lung cancer 3)Patients at stage IIIB/IV (including those who had recurrence after definitive treatment such as surgery or radiotherapy) 4)Patients with confirmed EGFR mutation (any variant type) 5)Patients who were treated at Department of Medical Oncology, Kinki University Faculty of Medicine or a joint study institution 6)Patients whose tumor tissue at baseline available for this study 7)Patients who were confirmed to have disease progression during EGFR-TKI treatment and whose tumor tissues have been obtained at subsequent biopsy 8)As for the patients who received Osimertinib, T790M mutation must be detected during the previous conventional EGFR-TKIs |
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Key exclusion criteria | Not established | |||
Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kindai University, Faculty of Medicine | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | 377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan | ||||||
TEL | 072-366-0221 | ||||||
hidet31@med.kindai.ac.jp |
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Name of contact person |
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Organization | Kindai University, Faculty of Medicine | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | 377-2 Ohno-higashi, Osaka-Sayama, 589-8511, Japan | ||||||
TEL | 072-366-0221 | ||||||
Homepage URL | |||||||
haratani_k@med.kindai.ac.jp |
Sponsor | |
Institute | Kindai university, Faculty of Medicine, Department of Medical Oncology |
Institute | |
Department |
Funding Source | |
Organization | AstraZeneca K.K. |
Organization | |
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Category of Funding Organization | Profit organization |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
Institutions | |
Institutions | 近畿大学
神奈川県立循環器呼吸器病センター 倉敷中央病院 岸和田市民病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Recruitment status | Enrolling by invitation | ||||||
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Other | |
Other related information | We will evaluate changes in tumor immune microenvironment, including PD-L1, CD73, TILs, and tumor mutation burden in the tumor tissues between before and after EGFR-TKI therapy by immunostaining and whole-exome sequencing in patients with EGFR mutation-positive advanced recurrent non-squamous non-small-cell lung cancer at Department of Medical Oncology, Kinki University Faculty of Medicine or a joint study institution. |
Management information | |||||||
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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=R000038757 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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