UMIN ID: UMIN000019627
Registered date:04/11/2015
Whole transcriptome analysis; human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | non-small cell lung cancer |
Date of first enrollment | 2015/11/04 |
Target sample size | 500 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | A: Lung cancer surgery with hANP treatment [Patients in the hANP group receive human ANP (0.025 microgram/kg/min for 3 days), which is started more than two hours before surgery] B: Surgery alone |
Outcome(s)
Primary Outcome | Clinicopathological character, overall survival, disease-free survival and gene differentiation (including microRNA, cell free DNA, and MUC4 gene mutation) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1. Thin-section CT fulfills the proportion of maximum diameter of the tumor itself to consolidation is less than 0.25. 2. Patient with active the other concurrent malignant diseases. 3. Women during pregnancy or breast-feeding. 4. Psychosis. 5. Systemic steroids or immunosuppressive agents medication. 6. Uncontrollable infectious disease, autoimmune disease, or the other severe comorbidities. 7. History of right ventricular infarction. 8. Severe hypotension 9. Other conditions judged ineligible by physician |
Related Information
Primary Sponsor | National Cerebral and Cardiovascular Center |
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Secondary Sponsor | |
Source(s) of Monetary Support | Shionogi & Co., Ltd. |
Secondary ID(s) |
Contact
public contact | |
Name | Takashi Nojiri |
Address | 5-7-1, Fujishiro-dai, Suita-city, Osaka, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka, Japan Japan |
Telephone | 06-6833-5012 |
nojiri@ri.ncvc.go.jp | |
Affiliation | National Cerebral and Cardiovascular Center Research Institute/Osaka University Hospital Biochemistry/General Thoracic Surgery |
scientific contact | |
Name | Kenji Kangawa/Meinoshin Okumura |
Address | 5-7-1, Fujishiro-dai, Suita-city, Osaka 565-8565, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka 565-0871, Japan Japan |
Telephone | 06-6833-5012 |
kangawa@ri.ncvc.go.jp | |
Affiliation | National Cerebral and Cardiovascular Center Research Institute/Osaka University Graduate School of Medicine Biochemistry/General Thoracic Surgery |