UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058678 |
|---|---|
| Receipt number | R000067095 |
| Scientific Title | Identifying the Utility and Challenges of a Collaborative Genetic Medicine Model through a Questionnaire Survey |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/08/02 17:25:47 |
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Basic information
Public title
Identifying the Utility and Challenges of a Collaborative Genetic Medicine Model through a Questionnaire Survey
Acronym
Identifying the Utility and Challenges of a Collaborative Genetic Medicine Model through a Questionnaire Survey
Scientific Title
Identifying the Utility and Challenges of a Collaborative Genetic Medicine Model through a Questionnaire Survey
Scientific Title:Acronym
Identifying the Utility and Challenges of a Collaborative Genetic Medicine Model through a Questionnaire Survey
Region
| Japan |
Condition
Condition
Hereditary Cancer Syndrome
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to identify the utility and challenges of a collaborative genetic care model between departments of clinical genetics and primary oncology physicians in the context of hereditary cancer management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the level of understanding of genetic medicine identified by comparing pre- and post-intervention questionnaire responses from healthcare professionals.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthcare Professionals:1.Aged 18 years or older 2. Medical professionals who are interested in hereditary cancer care (regardless of prior experience or certification)
Patients and Their Family Members:1. Aged 18 years or older 2. Individuals who seek genetic counseling in relation to hereditary cancer syndromes
Key exclusion criteria
Individuals Ineligible to Complete the Questionnaire
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | KOTA |
| Middle name | |
| Last name | ISHIOKA |
Organization
The Cancer Institute Hospital Of JFCR
Division name
Clinical Genetic Oncology
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo
TEL
+81-3-3520-0111
kota.ishioka@jfcr.or.jp
Public contact
Name of contact person
| 1st name | KOTA |
| Middle name | |
| Last name | ISHIOKA |
Organization
The Cancer Institute Hospital Of JFCR
Division name
Clinical Genetic Oncology
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo
TEL
+81-3-3520-0111
Homepage URL
kota.ishioka@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation of Cancer Research, JFCR
Institute
Department
Personal name
Funding Source
Organization
Pfizer Inc.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Cancer Institute Hospital Of JFCR
Address
3-8-31, Ariake, Koto, Tokyo
Tel
+81-3-3520-0111
kota.ishioka@jfcr.or.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | 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
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing to note
Management information
Registered date
| 2025 | Year | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067095
