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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030137
Receipt No. R000034412
Scientific Title Analysis of ALDH2 genotype in patients with hereditary breast and ovarian cancer
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/27

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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
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 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
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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
2017 Year 10 Month 13 Day
Date of IRB
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

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
2017 Year 11 Month 27 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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