Unique ID issued by UMIN | UMIN000022311 |
---|---|
Receipt number | R000025129 |
Scientific Title | Clinical performance study of a lung fusion kit |
Date of disclosure of the study information | 2016/05/23 |
Last modified on | 2019/10/29 15:53:15 |
Clinical performance study of a lung fusion kit
Clinical performance study of a lung fusion kit
Clinical performance study of a lung fusion kit
Clinical performance study of a lung fusion kit
Japan |
Non-small cell lung cancer
Hematology and clinical oncology |
Malignancy
NO
Evaluation of a lung fusion kit for diagnostic performance in fusion positive NSCLC
Others
Evaluation of a lung fusion kit for diagnostic performance
To compare the clinical performance of a lung fusion kit for ALK fusion diagnosis with that of a conventional IVD kit.
Sensitivity, specificity, and concordance in the detection of ALK gene fusions using a lung fusion kit.
Observational
Not applicable |
Not applicable |
Male and Female
1) Patients diagnosed with NSCLC
2) Formalin-fixed paraffin embedded tissues archived for a period less than 2 years
1) Formalin fixed paraffin embedded tissues archived for a period longer than two years
2) Patients diagnosed with EGFR mutation-positive NSCLC
3) Patients who are judged inappropriate to be enrolled in this study.
150
1st name | |
Middle name | |
Last name | Nishio Kazuto |
Kindai University Faculty of Medicine
Department of Genome Biology
377-2 Ohno-Higashi Osaka-Sayama, Osaka
072-366-0221
knishio@med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Sakai Kazuko |
Kindai University Faculty of Medicine
Department of Genome Biology
377-2 Ohno-Higashi Osaka-Sayama, Osaka
072-366-0221
kasakai@med.kindai.ac.jp
Department of Genome Biology, Kindai University Faculty of Medicine
Life Technologies Japan Ltd.
Profit organization
Tokyo Medical University
NO
2016 | Year | 05 | Month | 23 | Day |
none
Published
https://onlinelibrary.wiley.com/doi/full/10.1111/cas.14016
150
We used FFPE tissue samples of NSCLC from 150 EGFR mutation-negative cases and compared the performance of the Oncomine Dx Fusion Transcript Test (ODxFT) with FISH break-apart for the detection of ALK, RET, and ROS1 fusion genes. Concordance rate between the ODxFT and ALK-FISH analyses was 99.3%. Sensitivity and specificity were 91.7% and 99.3%, respectively. ODxFT was thus validated as an effective method for detecting clinically significant ALK fusion genes in FFPE tissue samples.
2019 | Year | 10 | Month | 29 | Day |
Non-small cell lung cancer
None
None
Rate of fusion genes
Completed
2016 | Year | 02 | Month | 15 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 05 | Month | 23 | Day |
2017 | Year | 04 | Month | 25 | Day |
Patients who were diagnosed with NSCLC at Kinki University Hospital and Tokyo Medical University Hospital and who satisfied predetermined criteria for the study.
Detection of a lung fusion genes (ALK, RET, ROS1, and NTRK1) using formalin-fixed paraffin embedded tissues.
2016 | Year | 05 | Month | 14 | Day |
2019 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025129
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |