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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047486
Receipt No. 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 2022/04/14

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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
Email 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
Email a.ono@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

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
Email 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
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 02 Month 21 Day
Date of IRB
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
2022 Year 04 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054152

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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