UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021084
Receipt number R000024320
Scientific Title Study to evaluate indication of endoscopic therapies for early colon cancer based on the colon cancer database
Date of disclosure of the study information 2016/02/18
Last modified on 2018/08/22 21:37:19

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Basic information

Public title

Study to evaluate indication of endoscopic therapies for early colon cancer based on the colon cancer database

Acronym

Study to evaluate indication of endoscopic therapies for early colon cancer

Scientific Title

Study to evaluate indication of endoscopic therapies for early colon cancer based on the colon cancer database

Scientific Title:Acronym

Study to evaluate indication of endoscopic therapies for early colon cancer

Region

Japan


Condition

Condition

Colonic cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the correlation between the pathological findings and lymph node metastasis of early colon cancer from a database of histopathological findings of early colon cancer treatment, and to re-examine the adaptation of endoscopic treatment of early colon cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Lymph node metastasis rate in early stage colon cancer

Key secondary outcomes

The positive rate of tumor cells in the immunostaining, vascular invasion rate, relationship between the results of protein expression including the mucus trait and the pathological factors, relationship between the prognosis and pathological factors, metastatic recurrence rate, and disease-free period


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

1) Cases which was performed endoscopic resection or surgical operation for early colonic cancer pathologically diagnosed between January 2000 to research approval date.
2) Cases obtained informed consent who will be performed endoscopic resection or surgical operation for early colonic cancer pathologically diagnosed between research approval date to March 2017.

Key exclusion criteria

Cases which can not be obtained informed consent, and which had been diagnosed with adenoma or advanced cancer in the pathological diagnosis.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinao Oda

Organization

Kyushu University

Division name

Department of Anatomic Pathology

Zip code


Address

Maidashi 3-1-1, Higashi-ku, Fukuoka

TEL

092-642-6061

Email

oda@surgpath.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiko Moriyama, Minako Hirahashi, Yuta Fuyuno

Organization

Kyushu University

Division name

Department of Medicine and Clinical Science

Zip code


Address

Maidashi 3-1-1, Higashi-ku, Fukuoka

TEL

092-642-5261

Homepage URL


Email

yfuyuno@intmed2.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Kyushu University

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


Address


Tel


Email



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

2016 Year 02 Month 18 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

2012 Year 12 Month 14 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is single center cohort study to evaluate the histopathological characteristics for early colonic cancer.


Management information

Registered date

2016 Year 02 Month 18 Day

Last modified on

2018 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024320


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name