UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035589
Receipt number R000017608
Scientific Title Invetigation whether SM depth is the risk factor of LNM.
Date of disclosure of the study information 2019/01/18
Last modified on 2021/02/23 13:57:18

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Basic information

Public title

Invetigation whether SM depth is the risk factor of LNM.

Acronym

Investigation of the importnce of measuring the depth of submucosal invasion in T1 colorectal carcinomas after endoscopic treatment.

Scientific Title

Invetigation whether SM depth is the risk factor of LNM.

Scientific Title:Acronym

Investigation of the importnce of measuring the depth of submucosal invasion in T1 colorectal carcinomas after endoscopic treatment.

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Investigate the importance of measuring the
depth of SM invasion in T1 colorectal cancer.

Basic objectives2

Others

Basic objectives -Others

Investigate whether SM depth is the risk factor of LNM, and the problem in measuring SM depth in T1 colorectal carcinomas.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Lymph node metastasis

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

1.T1 colorectal cancer
2.Patients who received complete treatment for cancer with initial or additional surgical resection
3.Written informed consent

Key exclusion criteria

1.Presence of synchronous or metachronous advanced colorectal cancer
2.Presence of malignant diseases in any other organs
3.Inflammatory bowel disease
4.familial adenomatous polyposis; FAP, Lynch Syndrome

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Yuta
Middle name
Last name Kouyama

Organization

Showa University Nothern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

2248503

Address

Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.

TEL

045-949-7000

Email

kouyuta1101@yahoo.co.jp


Public contact

Name of contact person

1st name Yuta
Middle name
Last name Kouyama

Organization

Showa University Nothern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

2248503

Address

Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.

TEL

045-949-7000

Homepage URL


Email

kouyuta1101@yahoo.co.jp


Sponsor or person

Institute

Digestive Disease Center, Showa University Nothern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

Showa University Northern Yokohama Hospital

Address

35-1, Chigasaki-Chuo Tsuzuki-ku, Yokohama-shi

Tel

0459497000

Email

kouyuta1101@yahoo.co.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

昭和大学横浜市北部病院(横浜市)


Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/26428364/

Number of participants that the trial has enrolled

568

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

2014 Year 08 Month 01 Day

Date of IRB

2014 Year 08 Month 30 Day

Anticipated trial start date

2014 Year 09 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective study


Management information

Registered date

2019 Year 01 Month 18 Day

Last modified on

2021 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017608


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name