UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047486 |
|---|---|
| Receipt number | R000054152 |
| Scientific Title | A single-center, backward-looking observational study on "Clinical development of a new endpoint of major pathological response for preoperative treatment of lung cancer using artificial intelligence and a digital pathology platform" |
| Date of disclosure of the study information | 2022/05/09 |
| Last modified on | 2024/04/15 09:29:09 |
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Basic information
Public title
Research on clinical development of a new clinical outcome (major pathological response) for preoperative treatment of lung cancer using artificial intelligence
Acronym
Research on clinical development of a new clinical outcome (major pathological response) for preoperative treatment of lung cancer using artificial intelligence
Scientific Title
A single-center, backward-looking observational study on "Clinical development of a new endpoint of major pathological response for preoperative treatment of lung cancer using artificial intelligence and a digital pathology platform"
Scientific Title:Acronym
A single-center, backward-looking observational study on "Clinical development of a new endpoint of major pathological response for preoperative treatment of lung cancer using artificial intelligence and a digital pathology platform"
Region
| Japan |
Condition
Condition
Non-small cell lung cancer patients who received preoperative treatment at our hospital from April 2002 to April 2021 and subsequently underwent surgery
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pathological response (PR) of preoperative treatment for lung cancer objectively and quantitatively using artificial intelligence, and to evaluate the relationship between the pathologist's evaluation of PR and MPR and the artificial intelligence's evaluation of PR and MPR.
Basic objectives2
Others
Basic objectives -Others
Evaluating MPR cutoff values to assess survival
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between PR and MPR evaluated by artificial intelligence and MPR and PR evaluated by pathologists
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Non-small cell lung cancer patients who received preoperative treatment at our hospital from April 2002 to April 2021 and subsequently underwent surgery and for whom FFPE block of the surgical specimen is available
Key exclusion criteria
There are no specific exclusion criteria.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Ono |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007 Shimonagakubo Sunto-gun Nagaizumi-cho
TEL
055-989-5222
a.ono@scchr.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ono |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007 Shimonagakubo Sunto-gun Nagaizumi-cho
TEL
055-989-5222
Homepage URL
a.ono@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
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
Ethics Review Committee for Exploratory Research, Shizuoka Cancer Center
Address
1007 Shimonagakubo Sunto-gun Nagaizumi-cho
Tel
055-989-5222
a.ono@scchr.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
ESR-20-21069
Org. issuing International ID_1
AstraZeneca K.K.
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 | 05 | Month | 09 | 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
50
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 | 02 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center, retrospective observational study
Management information
Registered date
| 2022 | Year | 04 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054152
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
