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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018480
Receipt No. R000021362
Scientific Title 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 2015/07/31
Last modified on 2020/08/01

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Basic information
Public title Human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial
Acronym Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery (JANP study)
Scientific Title Human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial
Scientific Title:Acronym Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery (JANP study)
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate whether human atrial natriuretic peptide (hANP) can reduce 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 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Two-year relapse free survival after lung cancer surgery
Key secondary outcomes 1. five-year relapse free survival after lung cancer surgery
2. Over all survival (5 years after surgery)
3. The ratio of the patients who completed the treatment
4. The incidence of postoperative complications

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
1st name Kenji Kangawa/Meinoshin Okumura
Middle name
Last name Kenji Kangawa/Meinoshin Okumura
Organization National Cerebral and Cardiovascular Center Research Institute/Osaka University Graduate School of Medicine
Division name Biochemistry/General Thoracic Surgery
Zip code 565-8565
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
1st name Takashi
Middle name
Last name Nojiri
Organization National Cerebral and Cardiovascular Center Research Institute/Osaka University Hospital
Division name Biochemistry/General Thoracic Surgery
Zip code 565-8565
Address 5-7-1, Fujishiro-dai, Suita-city, Osaka, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email nojiri@ri.ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
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)

IRB Contact (For public release)
Organization Osaka University Hospital
Address Osaka, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka, Japan
Tel 06-6833-5012
Email nojiri@ri.ncvc.go.jp

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
2015 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 332
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
2015 Year 06 Month 04 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
2022 Year 09 Month 30 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 29 Day
Last modified on
2020 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021362

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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