Unique ID issued by UMIN | UMIN000027030 |
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Receipt number | R000030989 |
Scientific Title | Assessment of reliability of small biopsy samples for tumor PD-L1 expression in non-small-cell lung cancer |
Date of disclosure of the study information | 2017/04/18 |
Last modified on | 2019/01/15 20:28:07 |
Assessment of reliability of small biopsy samples for tumor PD-L1 expression in non-small-cell lung cancer
PD-L1 expression in NSCLC with small biopsy samples
Assessment of reliability of small biopsy samples for tumor PD-L1 expression in non-small-cell lung cancer
PD-L1 expression in NSCLC with small biopsy samples
Japan |
Non-small-cell lung cancer
Pneumology |
Malignancy
NO
Programmed death 1 immune checkpoint inhibitor antibody was effective for patients with PD-L1 positive advanced NSCLC. However, the potency was estimated using surgically resected specimens or core needle biopsy samples in past large clinical trials. The aim of this study is to prospectively investigate the reliability of small samples of NSCLC in determining the PD-L1 expression status.
Efficacy
PD-L1 expression status of small samples with each procedure
(under rigid bronchoscopy, flexible bronchoscopy, CT & US-guided core-needle, excisional method)
1) Total number of tumor cells
2) Comparison of sample size, nunber of tumor cells and PD-L1 expression in BF 1T260 and BF P260F
3) Concordance rate of PD-L1 expression status in biopsy and surgical materials.
4) Efficacy for administration of PD-1 immune checkpoint inhibitor antibody
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Pathologically confirmed advanced non-small cell lung cancer (NSCLC)
2) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3) Patient with evaluable lesion based on RECIST
4) Written informed consent
Other cases attending physician it is determined unsuitable for registration of the study
100
1st name | |
Middle name | |
Last name | MASAMICHI MINESHITA |
St. Marianna University School of Medicine
Division of Respiratory Diseases, Department of Internal Medicine
2-16-1 Sugao Miyamae-ku, Kawasaki 216-8511
044-977-8111
m-mine@marianna-u.ac.jp
1st name | |
Middle name | |
Last name | KEI MORIKAWA |
St. Marianna University School of Medicine
Division of Respiratory Diseases, Department of Internal Medicine
2-16-1 Sugao Miyamae-ku, Kawasaki 216-8511
044-977-8111
mokke5454@yahoo.co.jp
St. Marianna University School of Medicine
St. Marianna University School of Medicine
Other
NO
2017 | Year | 04 | Month | 18 | Day |
Partially published
153 cases of PD-L1 expression were evaluated. 134 cases were sampled by bronchoscopy (111 EBUS-TBBs using BF-P260F/1T260 in 85/26 cases, 23 EBUS-TBNAs), and 19 were CT or US-guided core-needle biopsies. Tumor cell count and sample sizes were significantly larger for BF-1T260 than BF-P260F and EBUS-TBNA. Moreover, tumor cell counts for each subsequent biopsy decreased. The TPS (undiagnosed, under 1%, 1%-49%, over 50%) was 4/40/35/21% for EBUS-TBB using BF-P260F, 0/27/31/42% for using BF-1T260F, 0/22/26/52% for EBUS-TBNA, and 5/37/21/37% for CT or US-guided. In early stage adenocarcinoma, TPS was low. The concordance rate of TPS by biopsy and surgical materials was 86.7%.
No longer recruiting
2017 | Year | 04 | Month | 01 | Day |
2017 | Year | 04 | Month | 12 | Day |
No longer recruiting.
2017 | Year | 04 | Month | 18 | Day |
2019 | Year | 01 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030989
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