UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052789 |
|---|---|
| Receipt number | R000060028 |
| Scientific Title | Prospective observational study of genetic panel testing for health checkup participants |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2023/11/13 18:01:33 |
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Basic information
Public title
Prospective observational study of genetic panel testing for health checkup participants
Acronym
Prospective observational study of genetic panel testing for health checkup participants
Scientific Title
Prospective observational study of genetic panel testing for health checkup participants
Scientific Title:Acronym
Prospective observational study of genetic panel testing for health checkup participants
Region
| Japan |
Condition
Condition
Health checkup recipient
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In this study, we will introduce genetic panel testing at health checkup facilities and conduct a prospective observational study using questionnaires and epidemiological surveys to establish a health checkup model based on genomic information in the future healthcare field in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of high-risk individuals who are likely to carry pathogenic variants related to inherited tumors
Key secondary outcomes
Propotion of people requesting genetic counseling or panel testing among those eligible for health checkups
Changes in GCOS24, an evaluation scale for genetic counseling, between before and after genetic counseling(etc)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Members receiving a medical checkup at Kansai Medical Net
2 Members who can answer medical questionnaires and questionnaires (web)
3 Members who agree to participate in this research
Key exclusion criteria
1 Members who do not want to participate in this study
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Kawaguchi-Sakita |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8507
Address
54 Kawahara-cho Shogoin Sakyo-ku
TEL
+81-75-751-4326
nobuko75@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Usami |
Organization
Kansai Medical Net
Division name
customer support
Zip code
604-8436
Address
Shimadzu Plaza 4F, 11 Nishinokyo Shimoaicho, Nakagyo-ku, Kyoto City
TEL
06-7506-9018
Homepage URL
mss@k-medicalnet.co.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical Net
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
京都大学医学部附属病院（京都）、関西電力病院（大阪）、関西メディカルネット（大阪・京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 13 | 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
| 2023 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective cohort study introducing cancer-related genetic panel testing for people undergoing health checkups in Kansai Medical Net members. We will use interviews, questionnaires, and medical records to clarify the medical background of those seeking testing, the percentage of people who actually undergo genetic panel testing who have a pathogenic variant, expectations and evaluations of genetic counseling, behavioral changes, and surveillance.
Management information
Registered date
| 2023 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060028
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
