UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037056
Receipt number R000042138
Scientific Title Registration of patients with colorectal cancer in Department of Gastroenterological Surgery, Fukuoka University
Date of disclosure of the study information 2019/06/14
Last modified on 2019/06/13 16:26:51

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Basic information

Public title

Registration of patients with colorectal cancer in Department of Gastroenterological Surgery, Fukuoka University

Acronym

Registration of patients with colorectal cancer in Department of Gastroenterological Surgery, Fukuoka University

Scientific Title

Registration of patients with colorectal cancer in Department of Gastroenterological Surgery, Fukuoka University

Scientific Title:Acronym

Registration of patients with colorectal cancer in Department of Gastroenterological Surgery, Fukuoka University

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To investigate and analyze the data of registration data of colorectal cancer patients treated at Fukuoka University hospital

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Complication rate, survival and recurrence rate

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

Patients treated in our hospital between 4/1/2016 - 3/31/2021

Key exclusion criteria

judged as inappropriate for registration by physicial

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Suguru
Middle name
Last name Hasegawa

Organization

Faculty of medicine, Fukuoka University

Division name

Dept of Gastroenterological Surgery

Zip code

810-0180

Address

Nanakuma 7-45-1. Jonan, Fukuoka, JPN

TEL

0928011011

Email

shase@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Suguru
Middle name
Last name Hasegawa

Organization

Faculty of Medicine, Fukuoka University

Division name

Dept of Gastroenterological Surgery

Zip code

8140180

Address

Nanakuma 7-45-1. Jonan, Fukuoka, JPN

TEL

0928011011

Homepage URL


Email

shase@fukuoka-u.ac.jp


Sponsor or person

Institute

Dept of Gastroenterological Surgery
Faculty of Medicine, Fukuoka University

Institute

Department

Personal name



Funding Source

Organization

Dept of Gastroenterological Surgery
Faculty of Medicine, Fukuoka University

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

Medical Ethics Committee of Fukuoka University

Address

Nanakuma 7-45-1. Jonan, Fukuoka, JPN

Tel

0928011011

Email

fumed-ethics@fukuoka-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

2019 Year 06 Month 14 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

Enrolling by invitation

Date of protocol fixation

2018 Year 04 Month 02 Day

Date of IRB

2018 Year 09 Month 05 Day

Anticipated trial start date

2018 Year 09 Month 05 Day

Last follow-up date

2034 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

to investigate factors associated with patients survival, prognosis, safety and efficacy of the treatment


Management information

Registered date

2019 Year 06 Month 13 Day

Last modified on

2019 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042138


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name