UMIN-CTR Clinical Trial

Basic information
Public title	Development of a new biomarker for the detection of colorectal cancer using plasma concentrations of amino acids and metabolites
Acronym	Biomarker Development for the detection of colorectal cancer using amino acids and metabolites
Scientific Title	Development of a new biomarker for the detection of colorectal cancer using plasma concentrations of amino acids and metabolites
Scientific Title:Acronym	Biomarker Development for the detection of colorectal cancer using amino acids and metabolites
Region	Japan

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

Objectives
Narrative objectives1	To examine the possibility to develop a new biomarker for the detection of colorectal cancer using plasma concentrations of metabolites including amino acids in colorectal cancer patients and subjects undergoing health check-up
Basic objectives2	Others
Basic objectives -Others	To examine the relationship between plasma free amino acids/metabolites and other clinical parameters including adiponectin in subjects undergoing health check-up (without intervention)
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Plasma concentrations of metabolites that have amino moieties and other metabolites
Key secondary outcomes	Fasting blood glucose, HbA1c Tumor markers (CEA, CA19-9 etc.) Stage of cancer Site of cancer Result of pathological examination Tissue type of cancer Tumor size Clinical parameters obtained in health chek-up

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	25 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	A) Colorectal cancer patients (regardless of cancer stages). In Kyorin university, colorectal adenoma is also included. B) Age 25-90 C) People who agreed to the informed consent to participate in the study
Key exclusion criteria	A) Subjects who have taken any amino acid-formulations, supplements, and beverage within 8 hours before the blood collection. B) Subjects who have taken meals and beverage other than water within 8 hours before the blood collection. C) Subjects who are under medical treatment for any cancer including colorectal cancer (surgery, drug treatment, chemotherapy, radiation therapy) or who underwent surgery to remove cancer within 1 year. D) Subjects who have double cancer. E) Subjects who are pregnant or breast-feeding. F) Patients of inborn error of metabolism. G) Dialysis patients H) Subjects who are judged as ineligible by the medical doctors who are responsible for this trial as investigators.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hisamatsu Tadakazu
Organization	Kyorin University School of Medicine
Division name	The Third Department of Internal Medicine
Zip code
Address	6-20-2, Shinkawa, Mitaka-shi, Tokyo-to
TEL	0422-47-5511
Email	thisamatsu@ks.kyorin-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hidehiro Nakamura
Organization	Ajinomoto Co., Inc.
Division name	Research Institute for Bioscience Products & Fine Chemicals
Zip code
Address	1-1, Suzuki-cho, Kawasaki-ku, Kawsaki-shi, Kanagawa-ken
TEL	044-210-5835
Homepage URL
Email	hidehiro_nakamura@ajinomoto.com

Sponsor
Institute	Kyorin University School of Medicine The Third Department of Internal Medicine
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	杏林大学医学部付属病院（東京都）、社会医療法人 愛仁会 高槻病院（大阪府）、社会福祉法人 大阪府済生会千里病院（大阪府）、地方独立行政法人 りんくう総合医療センター（大阪府）、国保直営総合病院 君津中央病院（千葉県）、宗教法人在日本南プレスビテリアンミッション 淀川キリスト教病院（大阪府）、公立学校共済組合関東中央病院（東京都）、地域医療機能推進機構 東京高輪病院（東京都）、社会医療法人景岳会 南大阪病院（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 13 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	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 02 Day
Date of IRB	2017 Year 10 Month 02 Day
Anticipated trial start date	2017 Year 11 Month 13 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Profiles of plasma metabolites are compared between 400 colorectal cancer patients and approximately 2000 healthy controls who undergo a medical checkup. Using these data, an index to discriminate colorectal cancer patients is developed.

Management information
Registered date	2017 Year 11 Month 10 Day
Last modified on	2022 Year 11 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034127