UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042819
Receipt number R000048877
Scientific Title Observational study to grasp the current status of colonoscopy by Practical doctor
Date of disclosure of the study information 2020/12/22
Last modified on 2021/10/29 16:04:21

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Basic information

Public title

Observational study to grasp the current status of colonoscopy by Practical doctor

Acronym

Observational study to grasp the current status of colonoscopy by Practical doctor

Scientific Title

Observational study to grasp the current status of colonoscopy by Practical doctor

Scientific Title:Acronym

Observational study to grasp the current status of colonoscopy by Practical doctor

Region

Japan


Condition

Condition

Incident

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Grasping the current status and incidents of colonoscopy by Practical doctor

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)Correlation between mean cecal transit time and adenoma detection rate
2)Understanding of adverse events during colonoscopy

Key secondary outcomes

1)To search and comprehensively calculate descriptive statistics of obtained data.
2)Summarize adverse events and calculate descriptive statistics.


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All patients who underwent colonoscopy during the enrollment period at the participating institutions

Key exclusion criteria

The person who expressed a refusal after seeing the opt-out public document.

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Molecular-Targeting Prevention

Zip code

602-8566

Address

Kawaramachi-hiroko-ji, Kamigyo-ku, Kyoto 602-8566

TEL

075-251-5111

Email

cancer@gol.com


Public contact

Name of contact person

1st name Hideki
Middle name
Last name Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Molecular-Targeting Prevention

Zip code

602-8566

Address

Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN

TEL

0752515111

Homepage URL


Email

cancer@gol.com


Sponsor or person

Institute

Kyoto Prefectural University of Medicine
Molecular-Targeting Prevention

Institute

Department

Personal name



Funding Source

Organization

Practical Study Group on Colonoscopy

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine

Address

Kawaramachi-hiroko-ji, Kamigyo-ku, Kyoto 602-8566

Tel

0752515111

Email

rinri@koto.kpu-m.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

2020 Year 12 Month 22 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

Open public recruiting

Date of protocol fixation

2020 Year 12 Month 21 Day

Date of IRB

2021 Year 08 Month 02 Day

Anticipated trial start date

2021 Year 08 Month 20 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation: Medical records and questionnaires to facility representatives


Management information

Registered date

2020 Year 12 Month 22 Day

Last modified on

2021 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048877


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2022/04/28 市中クリニック観察研究:施設代表者アンケート_1ヶ月調査アンケート(固定用).xlsx