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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031515
Receipt No. 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 2018/02/28

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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
Middle name
Last name Manabu Muto
Organization Kyoto University Hospital
Division name Therapeutic Oncology
Zip code
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
Middle name
Last name Masahiro Yoshioka
Organization Kyoto University Hospital
Division name Therapeutic Oncology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL 075-751-3111
Homepage URL
Email yoshi0ka@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2016 Year 04 Month 15 Day
Last follow-up date
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
2018 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035093

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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