UMIN-CTR Clinical Trial

Basic information
Public title	Phase 1 study of human atrial natriuretic peptide during perioperative period for completely resected colorectal cancer
Acronym	Phase 1 study of hANP for colorectal cancer
Scientific Title	Phase 1 study of human atrial natriuretic peptide during perioperative period for completely resected colorectal cancer
Scientific Title:Acronym	Phase 1 study of hANP for colorectal cancer
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To invastigate safety of human atrial natriuretic peptide for perioperative period in patients with completely resected colorectal cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	hANP administration (0.025 maicrog/kg/min) is started at 2 hours before operation. hANP administration is continued for 3 days
Interventions/Control_2
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	1. Histologically or clinically proven completely resectable colorectal cancer 2. PS(ECOG):0-2 3. Adequate organ functions judged by laboratory tests 4. Written informed consent
Key exclusion criteria	1. previously hANP therapy 2. Participating the other clinical trial 3. obstruction of gastrointestinal tract 4. Active infectious disease 5. Uncontrollable severe comorbidities 6. Severe allergic history 7. Women during pregnancy or breast-feeding 8. Severe hypotension or cardiogenic shock 9. History of right ventricular infarction 10. hypovolemia 11. Other conditions judged ineligible by physician
Target sample size	7

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Mori
Organization	Osaka University Graduate School of Medicine
Division name	Depertment of gastroenterological surgery
Zip code	565-0871
Address	Yamadaoka 2-2, Suita city, Osaka
TEL	06-6879-3251
Email	mmori@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Hidekazu Middle name Last name Takahashi
Organization	Osaka University Graduate School of Medicine
Division name	Depertment of gastroenterological surgery
Zip code	565-0871
Address	Yamadaoka 2-2, Suita city, Osaka
TEL	06-6879-3251
Homepage URL
Email	htakahashi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University Graduate School of Medicine
Address	Yamadaoka 2-2, Suita city, Osaka
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-u.ac.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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	5
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	Main results already published
Date of protocol fixation	2017 Year 01 Month 27 Day
Date of IRB	2017 Year 01 Month 30 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 27 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029673