UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024319 |
|---|---|
| Receipt number | 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 09:36:01 |
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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
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
katayama@gancen.asahi.yokohama.jp
Sponsor or person
Institute
Kanagawa Cancer Center Research Institute
Cancer Prevention and Control Division
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028005
