UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017003
Receipt number 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 12:13:39

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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 or person

Institute

Okayama University

Institute

Department

Personal name



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

Value
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