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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002209
Receipt No. R000002715
Scientific Title Blood-based Early Detection Tests for Gastric Cancer Program, Pilot Clinical Study (Phase I)
Date of disclosure of the study information 2009/07/17
Last modified on 2014/04/22

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Basic information
Public title Blood-based Early Detection Tests for Gastric Cancer Program, Pilot Clinical Study (Phase I)
Acronym Early Detection Tests for Gastric Cancer Program
Scientific Title Blood-based Early Detection Tests for Gastric Cancer Program, Pilot Clinical Study (Phase I)
Scientific Title:Acronym Early Detection Tests for Gastric Cancer Program
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Development of biomarker for gastric cancer screening
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity and specificity of biomarhkers
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

Not applicable
Gender Male and Female
Key inclusion criteria "Subject has been screened for gastric cancer by endoscopy and confirmed as not having gastric cancer."or "Subject has been confirmed as having gastric cancer." Subject agrees to have cancer related blood test (excluding DNA/genetic tests) in the blood sample. Subject is willing to provide blood. Subject is willing to provide demographic and medical history information. Subject is competent to give written informed consent.
Key exclusion criteria Subject was taking experimental drug or anticancer drug within the past 30 days. Subject has been confirmed as having cancer in the past. Subject was confirmed as having cancer excluding gastric cancer at present. Major trauma or surgery within the past 3 months before study procedure. Subject is considered by the investigator to be an unsuitable candidate for this study.
Known or suspected infection with human immunodeficiency virus or infectious hepatitis.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiharu Yamaguchi
Organization Cancer Institute Ariake Hospital
Division name Gastroenterological Center
Zip code
Address 3-8-31 Ariake Kohtoh-ku Tokyo 135-8550, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Sakabe
Organization Alere Medical Co., Ltd.
Division name Technical Support
Zip code
Address 18F STEC Jyoho Building 1-24-1 Nishi-Shinjuku Shinjuku-ku, Tokyo 160-0023 Japan
TEL
Homepage URL
Email

Sponsor
Institute Alere San Diego Inc.
Institute
Department

Funding Source
Organization Alere San Diego Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2009 Year 07 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2009 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The usefulness of biomarkers for cancer screening is evaluated by measurement of their concentration in plasma/serum samples from non-gastric cancer subjects and gastric cancer patients.

Management information
Registered date
2009 Year 07 Month 15 Day
Last modified on
2014 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002715

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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