UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057915 |
|---|---|
| Receipt number | R000066205 |
| Scientific Title | Exploratory integrated Analysis to buIld a Pathologic finding, REcurrence,survival preDicting algorithm using artificial Intelligence from Clinical facTors andImage finding On thin section computed tomographyin patients with clinical stage IA Non-small cell lung cancer |
| Date of disclosure of the study information | 2025/05/20 |
| Last modified on | 2025/05/20 10:57:34 |
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Basic information
Public title
Exploratory integrated Analysis to buIld a Pathologic finding, REcurrence,survival preDicting algorithm using artificial Intelligence from Clinical facTors andImage finding On thin section computed tomographyin patients with clinical stage IA Non-small cell lung cancer
Acronym
AI PREDICTION
Scientific Title
Exploratory integrated Analysis to buIld a Pathologic finding, REcurrence,survival preDicting algorithm using artificial Intelligence from Clinical facTors andImage finding On thin section computed tomographyin patients with clinical stage IA Non-small cell lung cancer
Scientific Title:Acronym
AI PREDICTION
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An algorithm that predicts tissue classification from test data, such as imaging and blood tests, and clinical data obtained from clinical trials conducted by the Lung Cancer Surgery Group will be developed using artificial intelligence. After that, using retrospective data from the National Cancer Center Hospital East, the AI algorithm created in the former step will be used to perform transfer learning for prognosis and recurrence prediction, and an even more accurate prognosis and recurrence prediction algorithm will be developed.
Basic objectives2
Others
Basic objectives -Others
Developing prognosis and recurrence prediction algorithms using artificial intelligence for resectable non-small cell lung cancer
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Transfer learning of pathology prediction AI algorithms to construct prognosis and recurrence prediction algorithms
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cohort 1
Meet any of the following criteria.
1) Registered and eligible in JCOG0802/WJOG4607L from a JCOG participating institution.
2) Registered and eligible in JCOG0804/WJOG4507L from a JCOG participating institution.
3) Registered and eligible in JCOG1211.
Cohort 2
Meet all of the following criteria.
1) Non-small cell lung cancer (excluding low-grade tumors) operated on at the Department of Thoracic Surgery of the National Cancer Center Hospital East between January 2003 and December 2014.
2) Performance status (PS) is 0 or 1 according to the ECOG criteria.
3) Patients who have undergone pathological complete resection.
4) Age 80 years or younger at the time of surgery.
5) Clinical stage 0-IB.
6) Thin-section CT scans taken before surgery (with or without contrast, slice thickness: 10 mm or less) will be available to the study office.
7) Written informed consent to participate in this supplementary study has been obtained from surviving patients.
Key exclusion criteria
Cohort 1
1) CT images submitted for central image review did not include thin-section CT images of the main lesion.
Cohort 2
1) Patients had a history of other cancers at the time of surgery.
2) Multiple lung cancers were identified at the time of surgery.
3) Preoperative treatment had been performed.
4) The purpose of surgery was for biopsy or passive limited surgery.
5) The medical records did not contain sufficient data required for this supplementary study.
Target sample size
2509
Research contact person
Name of lead principal investigator
| 1st name | Keiju |
| Middle name | |
| Last name | Aokage |
Organization
National cancer center hospital EAST
Division name
Division of Thoracic Surgery
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
0471331111
kaokage@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Keiju |
| Middle name | |
| Last name | Aokage |
Organization
National Cancer Center Hospital East
Division name
Division of Thoracic Surgery
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
0471331111
Homepage URL
kaokage@east.ncc.go.jp
Sponsor or person
Institute
National cancer center
Institute
Department
Personal name
keiju Aokage
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB Office, National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
0471331111
kaokage@east.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JCOG2208A
Org. issuing International ID_1
Japan clincal oncology group
Study ID_2
Org. issuing International ID_2
IND to MHLW
千葉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 20 | 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
2509
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
The paper is currently being prepared.
Management information
Registered date
| 2025 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066205
