UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024901
Receipt number R000028317
Scientific Title Multicenter prospective cohort study of prognosis for T1 colorectal carcinoma
Date of disclosure of the study information 2017/01/01
Last modified on 2022/02/07 13:22:01

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Basic information

Public title

Multicenter prospective cohort study of prognosis for T1 colorectal carcinoma

Acronym

Cohort study of prognosis for T1 CRC

Scientific Title

Multicenter prospective cohort study of prognosis for T1 colorectal carcinoma

Scientific Title:Acronym

Cohort study of prognosis for T1 CRC

Region

Japan


Condition

Condition

Colorectal carcinoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the long-term outcomes more than 10 years among patients with T1 colorectal carcinoma in relation to the treatment methods, and the clinical validity of the Japanese Society for Cancer of the Colon and Rectum guidelines.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Recurrence rate

Key secondary outcomes

Disease free survival rate (5 years, 10 years)
Overall survival period(5 years, 10 years)
Outcomes after recurrence


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 with T1 colorectal carcinoma who underwent endoscopic resection or surgical resection

Key exclusion criteria

1)Colotic cancer
2)Familiar adenomatous polyposis
3)Synchronous colorectal invasive carcinoma (including previous history)
4)Active carcinoma of other organs

Target sample size

6000


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular-Targeting Cancer Prevention

Zip code

541-0042

Address

3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan

TEL

06-6202-5444

Email

cancer@gol.com


Public contact

Name of contact person

1st name Shiro
Middle name
Last name Oka

Organization

Hiroshima University Hospital

Division name

Department of Endoscopy

Zip code

734-8551

Address

1-2-3, kasumi, Minami-ku, Hiroshima

TEL

082-257-5939

Homepage URL


Email

oka4683@hiroshima-u.ac.jp


Sponsor or person

Institute

Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development, Ministry of Health, Labour and Welfare

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

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

Tel

075-251-5111

Email

m-muramatsu76@pref.kyoto.lg.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 01 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

1527

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

2016 Year 06 Month 13 Day

Date of IRB

2017 Year 03 Month 17 Day

Anticipated trial start date

2017 Year 06 Month 15 Day

Last follow-up date

2029 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

non


Management information

Registered date

2016 Year 11 Month 18 Day

Last modified on

2022 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028317


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2023/12/14 再:T1コホート研究データ_UMIN固定用_20231023.xlsx