UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study on biomarker search of gastrointestinal tumors by flow cytometry
Title of the study (Brief title)	Observational study on biomarker search of gastrointestinal tumors by flow cytometry
Region	Japan

Condition
Condition	Esophageal cancer, Gastric cancer, Colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Quantitatively evaluate the cell cycle status of the tumor tissue cells using a rapid flow cytometric machine called Celltac PEAK and compare it with the clinicopathological factor, therapeutic effect, prognosis and establish a new biomarker As the aim of this research.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	relapse free / progression-free survival period, pathology result, tumor marker etc., treatment effect (RECIST), numerical value measurable by image (tumor size, contrast effect, FDG-PET sugar metabolic rate, ADC value etc. ), Tumor genetic mutation (colon cancer)

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients aged 20 years or older who received a sufficient explanation about this research and received understanding and document consent by free will.
Key exclusion criteria	In the case of insufficient tissue volume for this examination during endoscopic examination or surgery. When consent on this research can not be obtained.
Target sample size	500

Research contact person
Name of lead principal investigator	Hisahiro Matsubara
Organization	Graduate school of medicine, Chiba University
Division name	Department of frontier surgery
Address	1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba
TEL	043-226-2109
Email	matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person	Hiroyuki Amagai
Organization	Graduate school of medicine, Chiba University
Division name	Department of frontier surgery
Address	1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba
TEL	043-226-2109
Homepage URL
Email	afua2633@chiba-u.jp

Sponsor
Institute	Graduate school of medicine, Chiba University
Institute
Department

Funding Source
Organization	NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
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 02 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 04 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	Analyze the DNA histogram of tissues using Celltac PEAK and quantitatively evaluate the cell cycle state of tumor cells in the tissue.

Management information
Registered date	2018 Year 02 Month 04 Day
Last modified on	2018 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035559