Unique ID issued by UMIN | UMIN000048870 |
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Receipt number | R000055694 |
Scientific Title | A multicenter study to evaluate the ability of NGS analysis of plasma samples to detect driver oncogenes in lung cancer |
Date of disclosure of the study information | 2022/09/07 |
Last modified on | 2023/09/26 11:23:30 |
A multicenter study to evaluate the ability of NGS analysis of plasma samples to detect driver oncogenes in lung cancer
A multicenter study evaluating the NGS analysis of plasma samples in lung cancer
A multicenter study to evaluate the ability of NGS analysis of plasma samples to detect driver oncogenes in lung cancer
A multicenter study evaluating the NGS analysis of plasma samples in lung cancer
Japan |
lung cancer
Pneumology |
Malignancy
NO
To evaluate whether NGS analysis using plasma samples can detect driver genes that would be a basis for administration of molecular targeted drug in patients who are scheduled for diagnosis with advanced stage non-small cell lung cancer and for initial treatment.
Others
In clinical practice, in cases of suspected advanced lung cancer, the presence or absence of driver genes is determined after the pathological diagnosis of non-small cell lung cancer is confirmed, and molecularly targeted therapies are used in those cases that test positive. The main objective of this study is to verify whether the results of NGS analysis of plasma samples are consistent with the results in clinical practice.
Exploratory
Explanatory
Not applicable
The concordance rate of gene subtypes diagnosis between based on pathology diagnosis and on plasma analysis
1. Efficacy of molecular targeted therapy (response rate, progression-free survival)
2. Detection rate of driver genes by plasma analysis
3. Rate of confirmed gene subtypes by plasma analysis in cases in which driver gene analysis was not possible
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Diagnosis
Device,equipment |
A blood draw is performed once from the time of planning the definitive diagnosis of lung cancer to before the start of chemotherapy, which is equivalent to first-line treatment. Blood samples will be collected at the time of the patient's visit to the hospital or incidental to the blood collection at the time of admission, and two blood collection tubes (approximately 14 ml) will be collected as needed. If consent is obtained for blood collection, samples will also be collected outside of medical appointments.
18 | years-old | <= |
Not applicable |
Male and Female
1) Cases in which advanced stage lung cancer is suspected and pathological diagnosis is being considered.
2) Cases in which curative treatment is not available and are expected to be treated with systemic treatment.
3) No prior systemic treatment. (Cases of recurrence after adjuvant chemotherapy or radical chemoradiotherapy that are considered prior to the first systemic treatment are acceptable.
4) Age: 18 years and older
5) Any PS (Performance status) is permitted.
6) Measurable lesions are not required.
non
1000
1st name | Ken |
Middle name | |
Last name | Uchibori |
Cancer Institute Hospital of Japan Foundation for Cancer Research
The Division of Thoracic Medical Oncology
135-8550
3-8-31, Ariake, Koto-Ku, Tokyo Japan
03-3520-0111
ken.uchibori@jfcr.or.jp
1st name | Ken |
Middle name | |
Last name | Uchibori |
Cancer Institute Hospital of Japan Foundation for Cancer Research
The Division of Thoracic Medical Oncology
135-8550
3-8-31, Ariake, Koto-Ku, Tokyo Japan
03-3520-0111
ken.uchibori@jfcr.or.jp
Cancer Institute Hospital of Japan Foundation for Cancer Research
Cabinet Office, Government of Japan
Japanese Governmental office
IRB office in Japan Foundation for Cancer Research
3-8-31, Ariake, Koto-Ku, Tokyo Japan
03-3520-0111
med.shinsa@jfcr.or.jp
NO
2022 | Year | 09 | Month | 07 | Day |
Unpublished
302
No longer recruiting
2022 | Year | 06 | Month | 06 | Day |
2022 | Year | 06 | Month | 14 | Day |
2022 | Year | 06 | Month | 15 | Day |
2024 | Year | 03 | Month | 31 | Day |
2022 | Year | 09 | Month | 07 | Day |
2023 | Year | 09 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055694
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