UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of rapid detection methods on cancer-related antigen in blood serum samples from gastric and colon cancer patients
Title of the study (Brief title)	Rapid detection methods on gastric and colon cancer-related antigen in blood serum samples
Region	Japan

Condition
Condition	Gastric cancer and colon cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery Laboratory medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Development of rapid detection methods on cancer-related antigen in blood serum from patients with digestive tract cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of cancer-related antigen.
Key secondary outcomes

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) patients with histologically proven gastric and colon cancer. And benign disease patients without cancer. (2) clinical solitary tumor (3) no prior treatment (4) age 20-80 years (5) Eastern Cooperative Oncology Group performance status 0 or 1 (6) sufficient organ function (7) written informed consent
Key exclusion criteria	(1) synchronous or metachronous malignancy (2) pregnant or breastfeeding women
Target sample size	90

Research contact person
Name of lead principal investigator	Hiroaki Ito, MD, PhD
Organization	Showa University Koto-Toyosu Hospital
Division name	Digestive Disease Center
Address	5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL	03-6204-6000
Email	h.ito@med.showa-u.ac.jp

Public contact
Name of contact person	Hiroaki Ito, MD, PhD
Organization	Showa University Koto-Toyosu Hospital
Division name	Digestive Disease Center
Address	5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL	03-6204-6000
Homepage URL
Email	h.ito@med.showa-u.ac.jp

Sponsor
Institute	Digestive Disease Center, Showa University Koto-Toyosu Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Digestive Disease Center, Showa University Koto-Toyosu Hospital
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	2013 Year 01 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 20 Day
Anticipated trial start date	2013 Year 01 Month 21 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	Published
URL releasing results
Results
Other related information	The possibility was showed that this technique could diagnose gastric and colonic cancer by using serum samples from the patients.

Management information
Registered date	2013 Year 01 Month 20 Day
Last modified on	2016 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011505