UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043723 |
|---|---|
| Receipt number | 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 | 2022/09/24 15:29:05 |
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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
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
ttsuda-tym@umin.ac.jp
Sponsor or person
Institute
Toyama Prefectural Central Hospital
Institute
Department
Personal name
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
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
No longer 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
| 2022 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049923
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