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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024319
Receipt No. R000028005
Scientific Title Changes in pre-operative and post-operative plasma free amino acid (PFAA) profiles of cancer patients
Date of disclosure of the study information 2016/10/06
Last modified on 2017/04/07

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Basic information
Public title Changes in pre-operative and post-operative plasma free amino acid (PFAA) profiles of cancer patients
Acronym Changes in pre and post-operative PFAA profiles of cancer patients
Scientific Title Changes in pre-operative and post-operative plasma free amino acid (PFAA) profiles of cancer patients
Scientific Title:Acronym 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
1st name
Middle name
Last name Kayoko Katayama
Organization Kanagawa Cancer Center Research Institute
Division name Cancer Prevention and Control Division
Zip code
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
1st name
Middle name
Last name Kayoko Katayama
Organization Kanagawa Cancer Center Research Institute
Division name Cancer Prevention and Control Division
Zip code
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)

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 10 Month 06 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 Completed
Date of protocol fixation
2010 Year 05 Month 13 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000028005

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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