UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056671 |
|---|---|
| Receipt number | R000064361 |
| Scientific Title | Acceptability Assessment for Cancer Risk Assessment Service |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2025/01/08 11:53:40 |
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Basic information
Public title
Acceptability Assessment for Cancer Risk Assessment Service
Acronym
Acceptability Assessment for Cancer Risk Assessment Service
Scientific Title
Acceptability Assessment for Cancer Risk Assessment Service
Scientific Title:Acronym
Acceptability Assessment for Cancer Risk Assessment Service
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the acceptability of a cancer risk evaluation service and identify challenges in the operational workflow, targeting individuals with a family history of cancer (e.g., siblings, parents).
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to evaluate the acceptability of a cancer risk evaluation service and identify challenges in the operational workflow, targeting individuals with a family history of cancer (e.g., siblings, parents).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood microRNA analysis
Participant interviews
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged between 40 and 70 at the time of consent.
2. Individuals who meet any of the following conditions:
2-1. Have siblings who have had colorectal cancer and are conscious of their high cancer risk.
2-2. Have parents who have had colorectal cancer and are conscious of their high cancer risk.
2-3. Have siblings who have had stomach cancer, esophageal cancer, or breast cancer and are conscious of their high cancer risk.
2-4. Have parents who have had stomach cancer, esophageal cancer, or breast cancer and are conscious of their high cancer risk.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who have been diagnosed with cancer or are currently suffering from cancer.
2. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
3. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
4. Individuals diagnosed with a mental illness such as depression or undergoing treatment within six months from the time of consent.
5. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
6. Individuals who donated 200 mL of their blood or blood components within the last month.
7. Individuals who donated 400 mL of his blood within the last 3 months.
8. Individuals who donated 400 mL of her blood within the last 4 months.
9. Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
10. Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
11. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kono |
Organization
Kewpie Corporation
Division name
Research and Development Division
Zip code
182-0002
Address
Sengawa Kewport 2-5-7 Sengawa-Cho, Chofu, Tokyo 182-0002, Japan
TEL
0353847759
yoshinori_kono@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
0362259001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
DiveDot Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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 | 01 | Month | 10 | 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 | 12 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted to evaluate the acceptability of a cancer risk assessment service among individuals who may have a high risk of cancer, such as those with a family history of cancer.
Management information
Registered date
| 2025 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064361
