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

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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 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

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

Value
https://center6.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