UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of circulating tumor cells(CTCs) and clinical significance of CTCs; human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial
Title of the study (Brief title)	Analysis of circulating tumor cells in the clinical study of ANP administration for lung cancer surgery (JANP study) (Subanalysis of JANP study)
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To detect circulating tumor cells(CTCs) and reveal the clinical significance of CTCs 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)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The presence of circulating tumor cells (CTCs) their morphological characteristics and clinicopathological character, overall survival and disease-free survival,
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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]
Interventions/Control_2	B: Surgery alone
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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
Key exclusion 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
Target sample size	500

Research contact person
Name of lead principal investigator	Kenji Kangawa/Meinoshin Okumura
Organization	National Cerebral and Cardiovascular Center Research Institute/Osaka University Graduate School of Medicine
Division name	Biochemistry/General Thoracic Surgery
Address	5-7-1, Fujishiro-dai, Suita-city, Osaka 565-8565, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka 565-0871, Japan
TEL	06-6833-5012
Email	kangawa@ri.ncvc.go.jp

Public contact
Name of contact person	Soichiro Funaki
Organization	Osaka University Graduate School of Medicine
Division name	General Thoracic Surgery
Address	2-2 (L5), Yamadaoka, Suita-City, Osaka 565-0871, Japan
TEL	06-6879-3152
Homepage URL
Email	funaki@thoracic.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	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）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 05 Month 31 Day
Anticipated trial start date	2015 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 05 Day
Last modified on	2016 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027988