UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049479 |
|---|---|
| Receipt number | R000056330 |
| Scientific Title | Mammography Screening for Japanese Women using Artificial Intelligence: A Randomized Crossover trial |
| Date of disclosure of the study information | 2022/11/11 |
| Last modified on | 2022/11/11 18:58:12 |
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Basic information
Public title
Mammography Screening for Japanese Women using Artificial Intelligence: A Randomized Crossover trial
Acronym
MAJIC trial
Scientific Title
Mammography Screening for Japanese Women using Artificial Intelligence: A Randomized Crossover trial
Scientific Title:Acronym
MAJIC trial
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate whether an artificial intelligence (AI) system developed for breast cancer diagnosis in mammography could improve readers' accuracy of diagnosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is an area under the receiver operating characteristic (ROC) curve (AUROC) of a likelihood of malignancy (LOM) score.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Read by readers with the use of artificial intelligence to support mammography reading.
Interventions/Control_2
Read by readers alone
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
Female
Key inclusion criteria
Digital mammograms fulfilling all the following criteria will be collected.
1. Images taken after 2010
2. Images meeting either one of the following criteria:
> Breast cancer or benign lesions are visible on the image
> Normal imaging
3. Cancer or benign lesions can be pointed out on the image
4. Images from patients aged 20 or older
5. Available mediolateral oblique view with or without a cranial-caudal view
6. No visible axillary lymph node metastasis from breast cancer
7. Images from patients with no previous history of chemotherapy, endocrine therapy, or radiotherapy
8. Images from patients who have not received any previous surgical breast procedure, including partial resection, breast reconstruction, incisional biopsy, vacuum-assisted biopsy, and mammoplasty
9. Read by mammography readers equivalent to rank A or AS according to the Japan Central Organization on Quality Assurance of Breast Cancer Screening
10. Benign lesions, breast cancer, and normal breast imaging are confirmed by the following methods:
(Benign lesions)
Meeting either one of the following criteria,
>Confirmed by histopathology
>If followed up, no change on the image is identified over at least two years
>Findings clearly indicating a simple cyst by mammography and other imaging modalities
(Breast cancer)
>Confirmed by histopathology
(Normal breast)
Meeting either one of the following criteria
>In addition to the mammography findings, other imaging modalities such as ultrasonography and MRI do not detect any lesions.
>If no other imaging studies are carried out, no new abnormalities develop over at least two years of follow-up.
11. Images taken at rank A or B institutions in the facility evaluation according to the Japan Central Organization on Quality Assurance of Breast Cancer Screening
12. Images from patients with written informed consent obtained
Key exclusion criteria
Digital mammograms fulfilling any of the following criteria will not be collected.
1. Tomosynthesis and synthetic 2D mammographic images
2. Images with spot compression views
3. Poor image quality
4. Inappropriate images, as judged by the local investigators
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Hirokaga |
Organization
Hyogo Cancer Center
Division name
Department of Breast Surgery
Zip code
673-8558
Address
13-70, Kitaoji-cho, Akashi-shi, Hyogo, 673-8558, Japan
TEL
078-929-1151
hirokaga@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Office |
| Middle name | |
| Last name | Comprehensive Support Project Oncological Research of Breast Cancer |
Organization
Comprehensive Support Project Oncological Research of Breast Cancer
Division name
Office
Zip code
277-0871
Address
Satellite no.502 in front of Kashiwanoha Campus, The University of Tokyo, 178-4-4 Wakashiba, Kashiwa
TEL
04-7135-5609
Homepage URL
office-bc@cspor-bc.or.jp
Sponsor or person
Institute
Comprehensive Support Project Oncological Research of Breast Cancer
Institute
Department
Personal name
Funding Source
Organization
Comprehensive Support Project Oncological Research of Breast Cancer
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Cancer Center IRB
Address
13-70, Kitaoji-cho, Akashi-shi, Hyogo, 673-8558, Japan
Tel
078-929-1151
rinsyoshikenkanri6@hyogo-cc.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
| 2022 | Year | 11 | Month | 11 | 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 | 06 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 11 | Month | 11 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056330
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