UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of the endoscopic findings after neoadjuvant chemotherapy for gastric cancer.
Title of the study (Brief title)	The efficacy of the endoscopic findings after neoadjuvant chemotherapy for gastric cancer.
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigated the relationship between endoscopic efficacy assessments before neoadjuvant chemotherapy and JCGC histological criteria in the gastric cancer patient who underwent chemotherapy before surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between endoscopic efficacy assessments before neoadjuvant chemotherapy and JCGC histological criteria in the gastric cancer patient who underwent chemotherapy before surgery
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	We included gastric cancer patients who underwent surgery after chemotherapy.
Key exclusion criteria	Linitis plastica.
Target sample size	50

Research contact person
Name of lead principal investigator	Kazuhide Higuchi
Organization	Osaka Medical College
Division name	Second Department of Internal Medicine
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Email	higuchi@osaka-med.ac.jp

Public contact
Name of contact person	Kazuhiro Ota
Organization	Osaka Medical College
Division name	Second Department of Internal Medicine
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Homepage URL
Email	clash_kaz@yahoo.co.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Retrospective study

Management information
Registered date	2018 Year 06 Month 21 Day
Last modified on	2018 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037731