Unique ID issued by UMIN | UMIN000019627 |
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Receipt number | R000022687 |
Scientific Title | 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 |
Date of disclosure of the study information | 2015/11/04 |
Last modified on | 2015/12/01 17:32:23 |
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
Whole transcriptome analysis in the clinical study of ANP administration for lung cancer surgery (JANP study) (Subanalysis of JANP study including genetic analysis)
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
Whole transcriptome analysis in the clinical study of ANP administration for lung cancer surgery (JANP study) (Subanalysis of JANP study including genetic analysis)
Japan |
non-small cell lung cancer
Chest surgery |
Malignancy
YES
To perform the global gene expression analysis including microRNA, cell free DNA, and MUC4 gene mutation for JANP study (human atrial natriuretic peptide for reducing the incidence of postoperative cancer recurrence in patients with completely resected non-small cell lung cancer)
Safety,Efficacy
Clinicopathological character, overall survival, disease-free survival and gene differentiation (including microRNA, cell free DNA, and MUC4 gene mutation)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
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
20 | years-old | <= |
Not applicable |
Male and Female
Preoperative criteria
1. Non-small cell lung cancer is suspected.
2. Thin-section CT fulfills the proportion of maximum diameter of the tumor itself to consolidation is more than 0.25.
3. It's possible to perfom the complete resection including mediastinal lymph node dissection.
4. Patient without simultaneous or metachronous (within the past 5 years) double cancers.
5. Aged more than 20 years
6. Performance status of 0-2.
7. Sufficient organ functions.
8. All patients gave written informed consent
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
500
1st name | |
Middle name | |
Last name | Kenji Kangawa/Meinoshin Okumura |
National Cerebral and Cardiovascular Center Research Institute/Osaka University Graduate School of Medicine
Biochemistry/General Thoracic Surgery
5-7-1, Fujishiro-dai, Suita-city, Osaka 565-8565, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka 565-0871, Japan
06-6833-5012
kangawa@ri.ncvc.go.jp
1st name | |
Middle name | |
Last name | Takashi Nojiri |
National Cerebral and Cardiovascular Center Research Institute/Osaka University Hospital
Biochemistry/General Thoracic Surgery
5-7-1, Fujishiro-dai, Suita-city, Osaka, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka, Japan
06-6833-5012
nojiri@ri.ncvc.go.jp
National Cerebral and Cardiovascular Center
Shionogi & Co., Ltd.
Profit organization
Japan
NO
大阪大学医学部附属病院(大阪府)
大阪府立成人病センター(大阪府)
国立病院機構刀根山病院(大阪府)
大阪府立呼吸器・アレルギー医療センター(大阪府)
北海道大学病院(北海道)
山形大学医学部附属病院(山形県)
山形県立中央病院(山形県)
東京大学医学部附属病院(東京都)
神戸大学医学部附属病院(兵庫県)
国立がん研究センター東病院(千葉県)
2015 | Year | 11 | Month | 04 | Day |
Unpublished
Open public recruiting
2015 | Year | 10 | Month | 30 | Day |
2015 | Year | 11 | Month | 04 | Day |
2022 | Year | 10 | Month | 31 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
The clinical trial registry number of main study (JANP study) is UMIN000018480.
2015 | Year | 11 | Month | 04 | Day |
2015 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022687
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