UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045992 |
|---|---|
| Receipt number | R000052501 |
| Scientific Title | Research of the algorithm development to detect rare driver gene-positive lung cancer population by histopathological image analysis using artificial intelligence |
| Date of disclosure of the study information | 2021/11/08 |
| Last modified on | 2023/04/11 10:21:18 |
* 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
Research of the algorithm development to detect rare driver gene-positive lung cancer population by histopathological image analysis using artificial intelligence
Acronym
Research of the algorithm for rare driver gene-positive lung cancer with using histopathological image and artificial intelligence
Scientific Title
Research of the algorithm development to detect rare driver gene-positive lung cancer population by histopathological image analysis using artificial intelligence
Scientific Title:Acronym
Research of the algorithm for rare driver gene-positive lung cancer with using histopathological image and artificial intelligence
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Develop the algorithm to detect rare driver gene-positive lung cancer population by histopathological image analysis using artificial intelligence, then evaluate it from clinical utility perspective.
Basic objectives2
Others
Basic objectives -Others
The performance of a detection evaluated by the area under the ROC curve, or AUC, for rare driver gene (ALK, ROS1, RET, BRAF, NTRK, MET, HER2, KRAS)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The performance of a detection evaluated by the area under the ROC curve, or AUC, for rare driver gene (ALK, ROS1, RET, BRAF, NTRK, MET, HER2, KRAS)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Non-small cell lung cancer
2. Histopathological image, genetic test results, clinical information, and imaging information
3. Written informed consent in LC-SCRUM-IBIS regarding secondary use of remaining sample and information
4. No rejection against secondary use of remaining sample and information, whose information is provided in the form of opt-out on the web-site
Key exclusion criteria
1. Patients whose participation in the trial is judged to be inappropriate by the doctor
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | GOTO |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Medical Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba
TEL
04-7133-1111
kgoto@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kiyotaka |
| Middle name | |
| Last name | YOH |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Medical Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba
TEL
04-7133-1111
Homepage URL
kyoh@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East / CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
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
NPO MINS
Address
1-15-14, Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
Npo-mins@j-irb.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
独立行政法人国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 08 | 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
982
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2021 | Year | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052501
