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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043723
Receipt No. R000049923
Scientific Title A study evaluating the effectiveness of back up by immunohistochemical staining in non-squamous non-small cell lung carcinoma cases where the driver gene is negative by standard examinations in Toyama.
Date of disclosure of the study information 2021/03/24
Last modified on 2021/03/31

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Basic information
Public title A study evaluating the effectiveness of back up by immunohistochemical staining in non-squamous non-small cell lung carcinoma cases where the driver gene is negative by standard examinations in Toyama.
Acronym A study evaluating the effectiveness of back up by immunohistochemical staining in non-squamous non-small cell lung carcinoma cases where the driver gene is negative by standard examinations in Toyama.
Scientific Title A study evaluating the effectiveness of back up by immunohistochemical staining in non-squamous non-small cell lung carcinoma cases where the driver gene is negative by standard examinations in Toyama.
Scientific Title:Acronym A study evaluating the effectiveness of back up by immunohistochemical staining in non-squamous non-small cell lung carcinoma cases where the driver gene is negative by standard examinations in Toyama.
Region
Japan

Condition
Condition Non-squamous non-small cell lung carcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluating the effectiveness of search by immunohistochemical staining in non-squamous non-small cell lung carcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percentage of positive cases of immunohistochemical staining and comparison with the results of tests that detect other genetic changes
Key secondary outcomes Percentage of cases treated with molecular-targeted therapies, presence or absence of response

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 Patients who meet all of the following (1) to (5) are targeted.
(1) Patients histopathologically diagnosed as non-squamous epithelial non-small cell lung cancer
(2) Patients who are undergoing or will be undergoing drug therapy due to the inability to perform curative radical radiation therapy or surgical treatment
(3) Patients for whom no significant genetic changes have been detected by standard genetic tests performed in daily practice, or patients for whom standard tests cannot be performed
(4) Patients who have residual paraffin-embedded blocks collected in the past and can be immunohistochemically stained
(5) Patients who explained to the person using the explanation consent document and obtained written consent
Key exclusion criteria No exclusion criteria will be set for cases that meet the selection criteria and are deemed appropriate by the attending physician.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Tsuda
Organization Toyama Prefectural Central Hospital
Division name The Department of Respiratory Medicine
Zip code 930-8550
Address 2-2-78 Nishinage, Toyama-city, Toyama 930-8550, Japan
TEL 076-424-1531
Email ttsuda-tym@umin.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Tsuda
Organization Toyama Prefectural Central Hospital
Division name The Department of Respiratory Medicine
Zip code 930-8550
Address 2-2-78 Nishinage, Toyama-city, Toyama 930-8550, Japan
TEL 076-424-1531
Homepage URL
Email ttsuda-tym@umin.ac.jp

Sponsor
Institute Toyama Prefectural Central Hospital
Institute
Department

Funding Source
Organization Toyama Prefectural Central Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toyama Prefectural Central Hospital
Address 2-2-78 Nishinage, Toyama-city, Toyama 930-8550, Japan
Tel 076-424-1531
Email byoin-keieikanri@esp.pref.toyama.lg.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 富山県立中央病院

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 24 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 Open public recruiting
Date of protocol fixation
2021 Year 02 Month 20 Day
Date of IRB
2021 Year 03 Month 22 Day
Anticipated trial start date
2021 Year 03 Month 24 Day
Last follow-up date
2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Immunohistochemical staining is relatively simple and can be diagnosed quickly, and even a relatively small amount of tissue such as a bronchoscopic sample can be examined, and its performance is relatively maintained even in a sample over time. There are a few reports of immunohistochemical staining testing for ROS-1, BRAF V600E, and NTRK gene changes in non-small cell lung carcinoma, it is reported high sensitivity and high specificity. However, these immunohistochemical stainings are not generally used in clinical practice in Japan under medical insurance. In particular, past report is not present on the screening of backups by multiple immunohistochemical stainings at the same time for a group of cases that are negative in the standard genetic test performed in Japan(or the standard test cannot be performed). Therefore, this time, we decided to carry out a single-center prospective observational study to examine effectiveness to perform three immunohistochemical staining tests, ROS-1, BRAF V600E, and PanTRK, for cases in which a significant genetic change is negative in the standard tests.

Management information
Registered date
2021 Year 03 Month 24 Day
Last modified on
2021 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049923

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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