UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of ALDH2 genotype in patients with hereditary breast and ovarian cancer
Acronym	ALDH2 genotyping in HBOC
Scientific Title	Analysis of ALDH2 genotype in patients with hereditary breast and ovarian cancer
Scientific Title:Acronym	ALDH2 genotyping in HBOC
Region	Japan

Condition
Condition	Hereditary breast and ovarian cancer
Classification by specialty	Hematology and clinical oncology Breast surgery Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We will examine the genotype of aldehyde calalyzing enzyme ALDH2, and determine whether it has an impact on development, severity, and survival of the patient with BRCA1/2 mutated HBOC cancer. The patients who was found to be BRCA1/2 mutation positive will be recruited.
Basic objectives2	Others
Basic objectives -Others	We will examine genetic interaction between BRCA1/2 and ALDH2 in carcinogenesis and biological characteristics of human cancer.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	BRCA1/2 mutation, ADH2 genotype, age of developing cancer, clinical stage, pathological diagnosis, overall survival, progression free survival
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
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Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The individuals whose BRCA1/2 genetic testing gave positive results.
Key exclusion criteria	The individuals whose BRCA1/2 genetic testing gave negative results.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Minoru Takata
Organization	Kyoto University
Division name	Radiation Biology Center
Zip code
Address	Yoshida konoecho, Sakyo-ku, Kyoto
TEL	075-753-7563
Email	mtakata@house.rbc.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Minoru Takata
Organization	Kyoto University
Division name	Radiation Biology Center
Zip code
Address	Yoshida konoecho, Sakyo-ku, Kyoto
TEL	075-753-7563
Homepage URL
Email	mtakata@house.rbc.kyoto-u.ac.jp

Sponsor
Institute	Kyouto University
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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Secondary IDs
Secondary IDs	YES
Study ID_1	G1105
Org. issuing International ID_1	Graduate School of Medicine, Kyoto University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	四国がんセンター(愛媛県）、愛知県がんセンター中央病院（愛知県）、昭和大学医学部　乳腺外科（東京都）、兵庫医科大学病院（兵庫県）、聖マリアンナ医科大学大病院（神奈川県）、徳島大学先端酵素学研究所（徳島県）、京都大学放射線生物研究センター（京都府）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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Results
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Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 13 Day
Date of IRB	2017 Year 11 Month 09 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry	2021 Year 03 Month 30 Day
Date trial data considered complete
Date analysis concluded	2022 Year 02 Month 28 Day

Other
Other related information	Blood or saliva will be collected from the patients, and genome DNA will be isolated. ALDH2 genotyping will be carried out by previously established Taqman PCR assay. The patients will be asked about their alcohol consumption habit using a questionnaire form.

Management information
Registered date	2017 Year 11 Month 27 Day
Last modified on	2021 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034412