UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025877
Receipt No. R000029673
Scientific Title Phase 1 study of human atrial natriuretic peptide during perioperative period for completely resected colorectal cancer
Date of disclosure of the study information 2017/02/01
Last modified on 2018/01/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Masaki Mori
Organization Osaka University Graduate School of Medicine
Division name Depertment of gastroenterological surgery
Zip code
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
Middle name
Last name Hidekazu Takahashi
Organization Osaka University Graduate School of Medicine
Division name Depertment of gastroenterological surgery
Zip code
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
Address
Tel
Email

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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2017 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
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
2018 Year 01 Month 29 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.