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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021934
Receipt No. R000025281
Scientific Title The investigation and development of serum peptide biomarker for early detection of colorectal cancer.
Date of disclosure of the study information 2016/04/18
Last modified on 2016/04/15

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Basic information
Public title The investigation and development of serum peptide biomarker for early detection of colorectal cancer.
Acronym The development of serum biomarker to detect early colorectal cancer.
Scientific Title The investigation and development of serum peptide biomarker for early detection of colorectal cancer.
Scientific Title:Acronym The development of serum biomarker to detect early colorectal cancer.
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Detection of colorectal cancer at early stage contributes for good prognosis of patients and decrease mortality. In this study, we aimed to detect effective and new serum biomarker for diagnose colorectal cancer using serum samples of colorectal cancer patients and healthy control.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The detection rate of colorectal cancer using new serum biomarker.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patients who are diagnosed as colorectal cancer.
2. The patients who were performed for the therapy of colorectal cancer.
3. The patients who have colorectal polyps.
4. The patients who do not have colorectal cancer and other malignancy for healthy control.
Key exclusion criteria 1. The patients who have malignant tumor instead of colorectal cancer.
2. The patients who have performed the treatment for malignant tumor instead of colorectal cancer.
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Uchiyama
Organization Kyoto Prefectural University of Medicinea
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Homepage URL
Email k-uchi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
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
2016 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially 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 Enrolling by invitation
Date of protocol fixation
2012 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The blood from the patients who agreed this study was put on at room temperature for 2 hours. Then the serum was gathered by centrifuge and kept at -80.
Then the serum will be analyzed by BLOT-CHIP method to detect peptide, and CE-MS method to detect metabolome which is correlated to colorectal cancer stage.

Management information
Registered date
2016 Year 04 Month 16 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=R000025281

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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