UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000017003
Receipt No. R000019691
Scientific Title Prospective cohort study to define the clinical and pathological features of lung cancers harboring HER2 gene aberrations.
Date of disclosure of the study information 2015/04/01
Last modified on 2022/05/16

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Basic information
Public title Prospective cohort study to define the clinical and pathological features of lung cancers harboring HER2 gene aberrations.
Acronym HER2-CS STUDY
Scientific Title Prospective cohort study to define the clinical and pathological features of lung cancers harboring HER2 gene aberrations.
Scientific Title:Acronym HER2-CS STUDY
Region
Japan

Condition
Condition Non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Define that HER2 positivity of non-small cell lung cancer
Basic objectives2 Others
Basic objectives -Others Exploring the charatristics of HER2 postive non-small cell lung cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Develpment of the criteria of HER2 postivity in NSCLC
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Non-small cell lung cancer with pathological confirmation
2. No radical treatment indication
3. Performance status 0-2
4. Patient with document agreement for this study
Key exclusion criteria There are no special instruction regarding this section.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Katsuyuki
Middle name
Last name Kiura
Organization Okayama University Hospital
Division name Allergy and respiratory medicine
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-Ku,Okayama
TEL 086-235-7227
Email kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Katsuyuki
Middle name
Last name Hotta
Organization Okayama University Hospital
Division name Allergy and respiratory medicine
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-Ku,Okayama
TEL 086-235-7227
Homepage URL
Email khotta@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Okayama University Hospital
Address 2-5-2 Shikata-cho, Kita-Ku
Tel 086-235-6503
Email ecm6938@adm.okayama-u.ac.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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 Day

Related information
URL releasing protocol doi: 10.1016/j.chest.2019.01.011.
Publication of results Published

Result
URL related to results and publications https://www.sciencedirect.com/science/article/pii/S0012369219300315?via%3Dihub
Number of participants that the trial has enrolled 1126
Results Of the 1,126 tumors screened, 34 (3.0%) were IHC3+, and 34 (3.0%) were IHC2+/FISH+. Among the 724 epidermal growth factor receptor wild-type tumors, 21 (2.9%) were HER2-mutant tumors, including A775-G776insYVMA (n = 15). Interestingly, the IHC3+ tumors and mutant tumors were entirely exclusive. Female patients had HER2-mutant tumors more frequently, whereas both IHC3+ and IHC2+/FISH+ tumors were detected more often in male subjects and smokers.
Results date posted
2022 Year 05 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 08 Month 01 Day
Baseline Characteristics Patients with pathologically confirmed stage IIIB/IV or recurrent NSCLC, Eastern Cooperative Oncology Group performance status 0 to 2, were prospectively registered.
Participant flow HER2 immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) assays were performed to screen patients.
Adverse events NA
Outcome measures The aim of this study was to clarify the frequency, characteristics, and outcome of HER2-positive NSCLC. HER2 was defined as positive if the tumor harbored IHC3+, IHC2+/FISH+, or exon 20 insertion mutations.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 10 Month 31 Day
Date of IRB
2015 Year 01 Month 27 Day
Anticipated trial start date
2015 Year 01 Month 27 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Completed

Management information
Registered date
2015 Year 04 Month 01 Day
Last modified on
2022 Year 05 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019691

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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