UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002209 |
|---|---|
| Receipt number | 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 14:00:25 |
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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
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
Sponsor or person
Institute
Alere San Diego Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002715
