UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in pre-operative and post-operative plasma free amino acid (PFAA) profiles of cancer patients
Title of the study (Brief title)	Changes in pre and post-operative PFAA profiles of cancer patients
Region	Japan

Condition
Condition	colorectal cancer, prostate cancer, breast cancer
Classification by specialty	Hepato-biliary-pancreatic surgery Breast surgery Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Plasma free amino-acid (PFAA) profiles show changes in a variety of cancer-type patients. We have used amino index technology for statistical analysis of PFAA profiles in healthy persons and persons with a cancer. As a result, Amino Index Cancer Screening (AICS) has been developed for early detection of seven types of cancer, including cancer, and it is now used in actual cancer screenings. The present study investigated patients who underwent curative resection for cancer, specifically in regards to preoperative to postoperative changes in AICS.
Basic objectives2	Others
Basic objectives -Others	Connects from exploratory research results to the hypothesis validation studies.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of AICS values pre and post-opration
Key secondary outcomes	Comparison of the tumor markers.

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	The subjects were patients with primary colon cancer who underwent curative resection at the Department of Gastroenterological Surgery at the Kanagawa Cancer Center between 2007 and 2014. The primary physician explained the study to the subjects and ensured that they understood the explanation, and then the subjects signed a written consent form. Patients who already had undergone treatment for cancer, patients with a previous history of cancer, and patients with metastatic or recurrent cancer were excluded from the study.
Key exclusion criteria	Patients already had done the treatment of cancer. Cases with a history of cancer. And metastasis of cancer. Recurrence of cancer.
Target sample size	100

Research contact person
Name of lead principal investigator	Kayoko Katayama
Organization	Kanagawa Cancer Center Research Institute
Division name	Cancer Prevention and Control Division
Address	2-3-2, Nakao, Asahi-ku, Yokohama city, 241-8515, Japan
TEL	045-520-2222
Email	katayama@gancen.asahi.yokohama.jp

Public contact
Name of contact person	Kayoko Katayama
Organization	Kanagawa Cancer Center Research Institute
Division name	Cancer Prevention and Control Division
Address	2-3-2, Nakao, Asahi-ku, Yokohama city, 241-8515, Japan
TEL	045-520-2222
Homepage URL
Email	katayama@gancen.asahi.yokohama.jp

Sponsor
Institute	Kanagawa Cancer Center Research Institute Cancer Prevention and Control Division
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 10 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 05 Month 13 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	It has been validated in colon cancer and prostate cancer patients as a verification site. Breast cancer cases was canceled for changes in mammary gland surgery attending physician, a research collaborator.

Management information
Registered date	2016 Year 10 Month 06 Day
Last modified on	2017 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028005