UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021350
Receipt number R000024620
Scientific Title Establishment of urinary biomarker panel for gastrointestinal cancers
Date of disclosure of the study information 2016/03/04
Last modified on 2022/09/08 15:07:41

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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 or person

Institute

Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



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

2012 Year 08 Month 01 Day

Anticipated trial start date

2012 Year 08 Month 06 Day

Last follow-up date

2023 Year 03 Month 31 Day

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

2022 Year 09 Month 08 Day



Link to view the page

Value
https://center6.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