UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Explore for biomarkers that are useful for detection of gastrointestinal cancer and prediction of therapeutic response of gastrointestinal cancer by analyzing circulating tumor DNA (ctDNA) and circulating tumor cells (CTC)
Title of the study (Brief title)	Diagnosis of gastrointestinal cancer using liquid biopsy
Region	Japan

Condition
Condition	Gastrointestinal cancer (esophageal cancer, stomach cancer, colorectal cancer)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Identification of predictive biomarkers for therapeutic response
Basic objectives2	Others
Basic objectives -Others	Identification of markers of early cancer detection
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Utility of biomarkers of gastrointestinal 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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. patients with gastrointestinal cancer 2. patients with suspected gastrointestinal cancer
Key exclusion criteria	1. patients with inherited colorectal cancer syndromes 2. patients with inflammatory bowel disease
Target sample size	200

Research contact person
Name of lead principal investigator	Eiji Kubota
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-851-5511
Email	ekubota@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Eiji Kubota
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-851-5511
Homepage URL
Email	ekubota@med.nagoya-cu.ac.jp

Sponsor
Institute	Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya Daini Red Cross Hospital, Nagoya City East Medical Center, West Medical Center, Toyokawa City Hospital, Tajimi Hospital, Chukyo Hospital, Kasugai Municipal Hospital, Gamagoori Municipal Hospital
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	2015 Year 05 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 01 Month 20 Day
Anticipated trial start date	2015 Year 02 Month 09 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	2015 Year 05 Month 01 Day
Last modified on	2018 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020156