UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030137 |
|---|---|
| Receipt number | 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 | 2021/11/30 10:44:26 |
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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 | Obstetrics 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
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
mtakata@house.rbc.kyoto-u.ac.jp
Sponsor or person
Institute
Kyouto University
Institute
Department
Personal name
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034412
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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