UMIN-CTR Clinical Trial

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

Colorectal Cancer

Classification by specialty

Gastroenterology

Laboratory medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyorin University School of Medicine
The Third Department of Internal Medicine

Institute

Department

Personal name

Organization

Ajinomoto Co., Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

11

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2017

Year

11

Month

10

Day

Last modified on

2022

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034127