UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031515
Receipt number R000035093
Scientific Title Development of Novel Ex Vivo Examination Kit To Detect HER2 Protein Overexpression in Gastric Cancer
Date of disclosure of the study information 2018/03/01
Last modified on 2023/03/04 09:09:27

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Basic information

Public title

Development of Novel Ex Vivo Examination Kit To Detect HER2 Protein Overexpression in Gastric Cancer

Acronym

Development of Novel Ex Vivo Examination Kit To Detect HER2 Protein Overexpression in Gastric Cancer

Scientific Title

Development of Novel Ex Vivo Examination Kit To Detect HER2 Protein Overexpression in Gastric Cancer

Scientific Title:Acronym

Development of Novel Ex Vivo Examination Kit To Detect HER2 Protein Overexpression in Gastric Cancer

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to develop a novel, easy, and prompt examination kit to diagnose HER2 protein overexpression using Trastuzumab, which is an antibody drug used to treat advanced gastric cancer patients with high expression of HER2 protein.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Concordance rate of the examination results of HER2 overexpression obtained by our novel kit and current procedure (immunohistochemistry and in situ hybridization) using endoscopic biopsy specimens of gastric cancer,

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have or are suspected to have gastric cancer and get esophagogastroduodenoscopic examination at Kyoto University Hospital.

Key exclusion criteria

Patients with high risk of bleeding after endoscopic biopsy.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Manabu
Middle name
Last name Muto

Organization

Kyoto University Hospital

Division name

Therapeutic Oncology

Zip code

606-8507

Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN

TEL

075-751-3111

Email

mmuto@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Yoshioka

Organization

Kyoto University Hospital

Division name

Therapeutic Oncology

Zip code

606-8507

Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN

TEL

075-751-3111

Homepage URL


Email

yoshi0ka@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

management expense of department of therapeutic oncology, Kyoto University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-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

2018 Year 03 Month 01 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

2016 Year 04 Month 14 Day

Date of IRB

2016 Year 04 Month 15 Day

Anticipated trial start date

2016 Year 04 Month 15 Day

Last follow-up date

2024 Year 04 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We now recruit candidates.


Management information

Registered date

2018 Year 02 Month 28 Day

Last modified on

2023 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035093


Research Plan
Registered date File name
2023/03/04 C1161-003_プロトコルver5_最終版.doc

Research case data specifications
Registered date File name
2023/03/04 C1161-003_プロトコルver5_最終版.doc

Research case data
Registered date File name
2023/03/04 C1161-003_プロトコルver5_最終版.doc