UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011182 |
|---|---|
| Receipt number | R000013073 |
| Scientific Title | Genomic examination and analysis for hereditary malignant tumors |
| Date of disclosure of the study information | 2013/07/12 |
| Last modified on | 2021/07/18 10:05:02 |
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Basic information
Public title
Genomic examination and analysis for hereditary malignant tumors
Acronym
Genomic examination and analysis for hereditary malignant tumors
Scientific Title
Genomic examination and analysis for hereditary malignant tumors
Scientific Title:Acronym
Genomic examination and analysis for hereditary malignant tumors
Region
| Japan |
Condition
Condition
herediraty breast and ovarian cancer, Cowden disease, Li-fraumeni syndrome, familial adenomatous polyposis, hereditary non-poliposis colon cancer
Classification by specialty
| Gastrointestinal surgery | Breast surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To establish programs of treatment and postoperative follow-up for hereditary cancer patients by accumulating the data of genomic mutations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of early detection program of hereditary cancers based on the results of genomic test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
Genetic test for BRCA1 and BRCA2 mutations
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
1. Patients with suspected herediary malignand disease.
2. Relatives of patients with comfirmed hereditary malignant disease.
3. Healthy members of a pedigree of suspected hereditary malignant disease.
Key exclusion criteria
1. Not enough for the criteria of the disease.
2. Client who doesn't receive pre-counseling.
3. Client younger than 20 y.o.
4. Client without a consent.
5. Client who cannot pay for the genetic test.
6. Client unsuitable for genetic test based on the ethical issue.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Tamaki |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Breast and Endocrine Surgery
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Tamaki |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Breast and Endocrine Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Familial Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Osaka Fundation for the prevention of cancer and cardiovascular diseases
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
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
| 2013 | Year | 07 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 12 | Day |
Last modified on
| 2021 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013073
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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