UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025142
Receipt number R000028914
Scientific Title Analysis of clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.
Date of disclosure of the study information 2017/01/01
Last modified on 2016/12/05 10:58:16

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Basic information

Public title

Analysis of clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.

Acronym

Analysis of colorectal tumors with MSI including Lynch syndrome.

Scientific Title

Analysis of clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.

Scientific Title:Acronym

Analysis of colorectal tumors with MSI including Lynch syndrome.

Region

Japan


Condition

Condition

Lynch syndrome
Colorectal tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To analyze clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.

Basic objectives2

Others

Basic objectives -Others

Investigate an actual condition

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.

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

Lynch syndrome patients who meet the Amsterdam criteria and the revised Bethesda guidelines.

Key exclusion criteria

none

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuji Takayama

Organization

Tokushima University Graduate School, The Institute of Biomedical Sciences, Department of Gastroenterology and Oncology

Division name

Gastroenterology and Oncology

Zip code


Address

3-18-15, Kyramoto-cho, Tokushima city

TEL

088-633-7122

Email

takayama@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fumika Nakamura

Organization

Tokushima University Graduate School, The Institute of Biomedical Sciences, Department of Gastroente

Division name

Gastroenterology and Oncology

Zip code


Address

3-18-15, Kyramoto-cho, Tokushima city

TEL

088-633-7122

Homepage URL


Email

fumiofumio@hotmail.com


Sponsor or person

Institute

Tokushima University Hospital, Department of Gastroenterology and Oncology

Institute

Department

Personal name



Funding Source

Organization

Tokushima University Hospital, Department of Gastroenterology and Oncology

Organization

Division

Category of Funding Organization

Non profit foundation

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

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


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

Preinitiation

Date of protocol fixation

2016 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome


Management information

Registered date

2016 Year 12 Month 05 Day

Last modified on

2016 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028914


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name