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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016879 |
Receipt No. | R000019596 |
Scientific Title | Mutation analyses of plasma and tumor DNA in EGFR mutation-positive advanced non-small-cell lung cancer. |
Date of disclosure of the study information | 2015/03/23 |
Last modified on | 2018/09/25 |
Basic information | ||
Public title | Mutation analyses of plasma and tumor DNA in EGFR mutation-positive advanced non-small-cell lung cancer. | |
Acronym | Liquid Biopsy Study | |
Scientific Title | Mutation analyses of plasma and tumor DNA in EGFR mutation-positive advanced non-small-cell lung cancer. | |
Scientific Title:Acronym | Liquid Biopsy Study | |
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 | YES |
Objectives | |
Narrative objectives1 | To investigate clinical benefit of liquid biopsy by measuring a somatic cell mutation such as EGFR gene mutation from peripheral circulating free DNA (tumor-specific circulating cell-free DNA: cfDNA) derived from plasma and DNA derived from tumors collected before and after treatment with EGFR-tyrosine kinase inhibitor (EGFR-TKI) using digital PCR and next-generation sequencer in patients with EGFR gene mutation-positive non-small-cell lung cancer. |
Basic objectives2 | Others |
Basic objectives -Others | Clinical benefit of liquid biopsy by measuring the somatic cell mutation such as EGFR gene mutation. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Detection of EGFR gene mutation from cfDNA collected before and after treatment with EGFR-TKI in patients with EGFR gene mutation- positive non-small-cell lung cancer. |
Key secondary outcomes | Detection of a biomarker about EGFR-TKI tolerance.
Coincidence ratio of detection of EGFR gene mutation between tissue samples and cfDNA. Association between the clinical background including a presence or absence of T790M gene mutation and the prognosis. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | 1)Patients with EGFR gene mutation (exon 19 deletion, L858R, G719X, L861M, T790M, etc) -positive non-small-cell lung cancer determined with a histological diagnosis or cytodiagnosis.
2)Patients with treatment plan of EGFR-TKI alone or combination therapy including EGFR-TKI. In addition, plasma samples of patients before treatment are stored at -80 degrees Celsius even if after the start of treatment. 3)Patients with more than 20 years. 4)Patients providing written informed consent. |
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Key exclusion criteria | 1) Patient with positive HBs antigen or HVC antibody.
2) Patient with definite positive HIV antibody (need not for examination). 3) Any other patients who are regarded as unsuitable for this study by the investigators. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyushu University Hospital | ||||||
Division name | Research Institute for Disease of the Chest / Center for Clinical and Translational Research | ||||||
Zip code | |||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka-city, Fukuoka 812-8582, Japan | ||||||
TEL | 092-642-5378 | ||||||
okamotoi@kokyu.med.kyushu-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Graduate School of Medical Sciences, Kyushu University | ||||||
Division name | Research Institute for Disease of the Chest | ||||||
Zip code | |||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka-city, Fukuoka 812-8582, Japan | ||||||
TEL | 092-642-5378 | ||||||
Homepage URL | |||||||
noriko-f@kokyu.med.kyushu-u.ac.jp |
Sponsor | |
Institute | Clinical Research Support Center Kyushu |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labour and Welfare. |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization | Japan |
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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 |
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 | |
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Results | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | Peripheral blood (7ml, EDTA-2Na) is collected before treatment with EGFR-TKI (from -4 weeks to treatment start day) and at 12 weeks, at 24weeks, at 36 weeks, after every 12 weeks (the allowance day: 1 week) after treatment start and at disease progression (within 2 weeks after PD confirmation).
The submission of tumor samples is not essential. However, the following samples are submitted to investigate the correlation between tumor sample and cfDNA about having T790M gene mutation or not, in the cases that one of the following samples (no limit at collection time) are stored before start of EGFR-TKI treatment, or a re-biopsy is carried out from the progression of disease during treatment with EGFR-TKI. /Six pieces of slide specimens which performed slicing to a 4-5 microns thickness of the paraffin embedded specimen. /One piece of prepared slide (Papanicolaou stain) used for a cytodiagnosis. /Twenty ml (10mLx2) of malignant pleural effusion was centrifuged (1400g for 10min at room temperature), and stored two pellets at -80 degrees Celsius after removal of a supernatant. The supernatant is not removed too much (leave around 1cm). /DNA extract (samples after EGFR gene mutation examination) /Cell block |
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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=R000019596 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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