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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009818
Receipt No. R000011505
Scientific Title Development of rapid detection methods on cancer-related antigen in blood serum samples from gastric and colon cancer patients
Date of disclosure of the study information 2013/01/20
Last modified on 2016/04/15

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Basic information
Public title Development of rapid detection methods on cancer-related antigen in blood serum samples from gastric and colon cancer patients
Acronym Rapid detection methods on gastric and colon cancer-related antigen in blood serum samples
Scientific Title Development of rapid detection methods on cancer-related antigen in blood serum samples from gastric and colon cancer patients
Scientific Title:Acronym 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

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
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
1st name
Middle name
Last name Hiroaki Ito, MD, PhD
Organization Showa University Koto-Toyosu Hospital
Division name Digestive Disease Center
Zip code
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
1st name
Middle name
Last name Hiroaki Ito, MD, PhD
Organization Showa University Koto-Toyosu Hospital
Division name Digestive Disease Center
Zip code
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

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)

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
2013 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 01 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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