UMIN-CTR Clinical Trial

Basic information
Public title	How many biopsies should we take to precisely diagnose HER2 expression of gastric cancer?
Acronym	How many biopsies should we take to precisely diagnose HER2 expression of gastric cancer?
Scientific Title	How many biopsies should we take to precisely diagnose HER2 expression of gastric cancer?
Scientific Title:Acronym	How many biopsies should we take to precisely diagnose HER2 expression of gastric cancer?
Region	Japan

Condition
Condition	Advanced gastric cancer
Classification by specialty	Gastroenterology Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluated suitable site and number of biopsies for clinical management of gastric cancer needed chemotherapy because of various histological types and heterogeneity of HER2 expression.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluate the histological type and HER2 expression of six biopsy specimens.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	We administer six biopsies from tumor: Two are on the surface of oral side, two are center, and two are anal side.
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	1) The patients who are scheduled for surgery. 2) The patients who make one's own decision to this study.
Key exclusion criteria	1) Performance Status (PS) 3 or 4. 2) The patient who has serious complications to other organs except the original illness (ASA grade more than 3). 3) The patient who cannot go off an anticoagulant therapy. 4) The patient who is judged high risk of complications on the operation. 5) The patients who does not hope for an operation or who is judged that an operation is inappropriate. 6) In addition, the patients who is judged that an operation is inappropriate by physician's own standard.
Target sample size	62

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoyuki Tominaga
Organization	Tokyo medical university
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Email	aeras_nt@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Naoyuki Tominaga
Organization	Tokyo medical university
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Homepage URL
Email	aeras_nt@yahoo.co.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Tokyo medical university
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Tokyo medical university
Organization
Division
Category of Funding Organization
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	2015 Year 03 Month 31 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	Terminated
Date of protocol fixation	2014 Year 01 Month 22 Day
Date of IRB	2014 Year 01 Month 22 Day
Anticipated trial start date	2014 Year 01 Month 22 Day
Last follow-up date	2016 Year 01 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 02 Month 01 Day
Last modified on	2020 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015201