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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021350
Receipt No. R000024620
Scientific Title Establishment of urinary biomarker panel for gastrointestinal cancers
Date of disclosure of the study information 2016/03/04
Last modified on 2020/03/07

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Basic information
Public title Establishment of urinary biomarker panel for gastrointestinal cancers
Acronym Urinary biomarker for GI cancers
Scientific Title Establishment of urinary biomarker panel for gastrointestinal cancers
Scientific Title:Acronym Urinary biomarker for GI cancers
Region
Japan

Condition
Condition Gastric cancer, Colorectal cancer, Esophageal cancer
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Discovery of urinary biomarker for early diagnosis, prognosis and prediction of GI cancers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Accuracy, Sensitivity, Specificity, Area under the curve
Key secondary outcomes Discovery of serum biomarker

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
90 years-old >=
Gender Male and Female
Key inclusion criteria (Healthy control)
1.No findings of malignacy
2.Age from 20 to 90 years old
3.Agreement with a written informed consent

(Cancer cohort)
1.Gastrointestinal neoplasms
2.Age from 20 to 90 years old
3.Agreement with a written informed consent
Key exclusion criteria 1.Previous history of any cancers (within 5 years for cancer cohort)
2.Multiple malignancies
3.Inappropriateness by doctor's judgement
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Takaya
Middle name
Last name Shimura
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-853-8211
Email tshimura@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Takaya
Middle name
Last name Shimura
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-853-8211
Homepage URL
Email tshimura@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 Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Okazaki Public Health Center
Japanese Red Cross Nagoya Daini Hospital
Harvard Medical School and Boston Childrens Hospital
National Institutes of Health/National Cancer Institute
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Management Center, Nagoya City University Hospital
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
Tel 052-858-7215
Email clinical_research@med.nagoya-cu.ac.jp

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 名古屋市立大学病院(愛知県)、岡崎医師会公衆衛生センター(愛知県)、名古屋第二赤十字病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 04 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 Open public recruiting
Date of protocol fixation
2012 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Enrollment patients with esophageal, gastric, and colorectal cancers and healthy population at participating facilities in this study.
Analysis of urinary protein, peptide, metabolite, miRNA and so on to discover diagnostic, prognostic and predictive biomarkers for GI cancers.

Management information
Registered date
2016 Year 03 Month 04 Day
Last modified on
2020 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024620

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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