UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048869 |
|---|---|
| Receipt number | R000055693 |
| Scientific Title | Exploratory integrated analysis to build a pathologic finding, recurrence, survival predicting algorithm using artificial intelligence from clinical factors and image finding on thin-section computed tomography in patients with clinical stage IA non-small cell lung cancer |
| Date of disclosure of the study information | 2022/09/07 |
| Last modified on | 2022/09/07 12:03:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory integrated analysis to build a pathologic finding, recurrence, survival predicting algorithm using artificial intelligence from clinical factors and image finding on thin-section computed tomography in 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 and image finding on thin-section computed tomography in 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
To develop the prediction model of cancer recurrence or pathological findings in lung cancer patients with stage I NSCLC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic sensitivity and specificity of prediction of cancer recurrence by artificial intelligence prediction model.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
Cohort 1
Satisfy one of the following.
1) Registered and eligible in JCOG0802/WJOG4607L
2) Registered and eligible in JCOG0804/WJOG4507L
3) Registered and eligible in JCOG1211.
Cohort 2
All of the following items are satisfied.
1) Non-small cell lung cancer (excluding low-grade malignant tumors) operated at the Department of Thoracic Surgery, National Cancer Center Hospital East from January 2003 to December 2014.
2) Performance status (PS) is 0 or 1 according to ECOG criteria.
3) Complete pathological resection.
4) 80 years old or younger at the time of surgery.
5) Clinical stage 0-IB.
6) Preoperative thin-section CT (with or without contrast enhancement, slice thickness: 10 mm or less) can be obtained by the research office.
7) Written informed consent has been obtained from the survivors to participate in this study.
Key exclusion criteria
Cohort 1
1) No thin-section image of the main tumor in CT images submitted for central image review
Cohort 2
1) A history of other cancers at the time of surgery.
2) Multiple lung cancers were observed at the time of surgery.
3) Preoperative treatment was performed.
4) The purpose of the surgery was biopsy or sublobar resection for compromised patients.
5) Insufficient data in the medical record required for this ancillary study.
Target sample size
3129
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsuboi |
Organization
National cancer center hospital East
Division name
Department of thoracic surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
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
Department of thoracic surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
0471331111
Homepage URL
kaokage@east.ncc.go.jp
Sponsor or person
Institute
JCOG
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
M3 Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital, East, Japan
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
Tel
0471331111
irst@ncc.go.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
国立がん研究センター東病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 07 | 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
| 2022 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 09 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055693
