UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046925 |
|---|---|
| Receipt number | R000053522 |
| Scientific Title | miSignal cancer risk screening follow-up study |
| Date of disclosure of the study information | 2022/02/16 |
| Last modified on | 2024/03/18 10:41:05 |
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Basic information
Public title
miSignal cancer risk screening follow-up study
Acronym
miSignal cancer risk screening follow-up study
Scientific Title
miSignal cancer risk screening follow-up study
Scientific Title:Acronym
miSignal cancer risk screening follow-up study
Region
| Japan |
Condition
Condition
Lung cancer, Breast cancer, Esophageal cancer, Stomach cancer, Pancreatic cancer, Colon cancer, Ovarian cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the real-world performance of miSignal cancer risk screening test, which uses urinary miRNAs to predict the risk of cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cancer detection rate and accuracy (sensitivity and specificity) of miSignal
Key secondary outcomes
Cancer detection rate and accuracy (sensitivity and specificity) in combination with other cancer screening methods and miSignal.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. miSignal users
2. The age of 20 years and above
3. Obtained written consent to participate in this study.
Key exclusion criteria
1. Pregnant woman
2. Subjects who have a history of cancer
3. Subjects whom the principal investigator evaluates unsuitable to participate in this study for any other reason.
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Ichikawa |
Organization
Craif Inc.
Division name
CTO
Zip code
113-0033
Address
5F Hongo ITP Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
TEL
03-6801-8334
yuki.ichikawa@craif.com
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Nishiyama |
Organization
Craif Inc.
Division name
Clinical research office
Zip code
1050003
Address
5F Hongo ITP Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
TEL
03-6801-8334
Homepage URL
clinicaltrial@craif.com
Sponsor or person
Institute
Craif Inc.
Institute
Department
Personal name
Funding Source
Organization
Self-financing
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
Craif Independent Ethics Committee
Address
5F Hongo ITP Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
Tel
03-6801-8334
hatsumi.goto@craif.com
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
| 2022 | Year | 02 | Month | 16 | 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
| 2022 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
n/a
Management information
Registered date
| 2022 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053522
