UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056304 |
|---|---|
| Receipt number | R000064339 |
| Scientific Title | Implementation of a Cancer Risk Assessment Program Using Genetic Testing in the General Female Population |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/11/29 12:28:49 |
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Basic information
Public title
Implementation of a Cancer Risk Assessment Program Using Genetic Testing in the General Female Population
Acronym
Implementation of a Cancer Risk Assessment Program Using Genetic Testing
Scientific Title
Implementation of a Cancer Risk Assessment Program Using Genetic Testing in the General Female Population
Scientific Title:Acronym
Implementation of a Cancer Risk Assessment Program Using Genetic Testing
Region
| Japan |
Condition
Condition
Hereditary cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the feasibility of providing a hereditary tumor risk assessment program to women in the general population
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Program completion rate
Key secondary outcomes
- Completion rate of the family and medical history screening questionnaire
- Proportion of individuals with pathogenic variants among the study participants
- Proportion of study participants meeting the criteria for genetic testing
- Proportion of individuals with pathogenic variants among those who underwent genetic testing
- Proportion of individuals with detected pathogenic variants who received genetic counseling
- Proportion of individuals meeting genetic testing criteria by level of criteria
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Gene |
Interventions/Control_1
Study participants will undergo a hereditary tumor risk assessment program designed for the general population. In this program, genetic testing is recommended if their family and medical history meet certain criteria, and participants can freely decide whether to undergo the testing.
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Use age and gender as the only selection criteria.
Key exclusion criteria
- Individuals diagnosed with hereditary tumors
- Individuals whose close relatives have been diagnosed with hereditary tumors and who have access to genetic counseling as a relative
- Individuals with a confirmed germline pathogenic variant in the BRCA1 and/or BRCA2 genes within their family
- Individuals unable to answer the questionnaire
- Individuals unable to communicate in Japanese
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Narimatsu |
Organization
Kanagawa Cancer Center Research Institute
Division name
Cancer Prevention and Control Division
Zip code
241-8515
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa
TEL
045-520-2222
hiroto-narimatsu@umin.org
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Narimatsu |
Organization
Kanagawa Cancer Center Research Institute
Division name
Cancer Prevention and Control Division
Zip code
241-8515
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa
TEL
045-520-2222
Homepage URL
hiroto-narimatsu@umin.org
Sponsor or person
Institute
Kanagawa Cancer Center Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Institute of Industrial Science and Technology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
You-wa-kai Medical Corporation Association
Name of secondary funder(s)
ACTmed Co., Ltd
IRB Contact (For public release)
Organization
Kanagawa Cacner Center
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa
Tel
045-520-2222
clinical_trials@kcch.jp
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
湘南健診クリニック ココットさくら館
Other administrative information
Date of disclosure of the study information
| 2024 | 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
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064339
