UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025877 |
|---|---|
| Receipt number | 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 | 2021/05/25 15:59:45 |
* 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 | 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
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
htakahashi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029673
