UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005466
Receipt number R000006087
Scientific Title Quantification of DNA injury of surrounding mucosa in alcohol-related cancers
Date of disclosure of the study information 2011/04/19
Last modified on 2013/05/30 22:55:30

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Basic information

Public title

Quantification of DNA injury of surrounding mucosa in alcohol-related cancers

Acronym

Quantification of Alcohol-related DNA adducts

Scientific Title

Quantification of DNA injury of surrounding mucosa in alcohol-related cancers

Scientific Title:Acronym

Quantification of Alcohol-related DNA adducts

Region

Japan


Condition

Condition

Esophageal cancer, Gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Assessment of DNA injury derived from acetaldehyde.

Basic objectives2

Others

Basic objectives -Others

basic research

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

DNA Adducts level of esophageal and gastric muocosa

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Esophageal cancer patients
Gastric cancer patients

Key exclusion criteria

History of radiation therapy
History of chemotherapy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Manabu Muto

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan

TEL

075-751-4319

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshiyuki Yukawa

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan

TEL

075-751-4319

Homepage URL


Email

yoshitak@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Research Center for Environmental Quality Management, Kyoto University

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

2011 Year 04 Month 19 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

No longer recruiting

Date of protocol fixation

2009 Year 12 Month 24 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date

2011 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2014 Year 10 Month 31 Day

Date analysis concluded

2014 Year 12 Month 31 Day


Other

Other related information

Drinking history, smoking history and SNP of alcohol-related metabolyzing enzymes.


Management information

Registered date

2011 Year 04 Month 19 Day

Last modified on

2013 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006087


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name