UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011585 |
|---|---|
| Receipt number | R000013547 |
| Scientific Title | Examination about the change of transforming growth factor-beta 1 enzyme in the medical treatment mainly on the diet cure in the cancer patient |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2020/03/01 21:52:09 |
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Basic information
Public title
Examination about the change of transforming growth factor-beta 1 enzyme in the medical treatment mainly on the diet cure in the cancer patient
Acronym
Change of transforming growth factor-beta 1 in the cancer patient
Scientific Title
Examination about the change of transforming growth factor-beta 1 enzyme in the medical treatment mainly on the diet cure in the cancer patient
Scientific Title:Acronym
Change of transforming growth factor-beta 1 in the cancer patient
Region
| Japan |
Condition
Condition
For the all cancer, regardless of cancer as the underlying disease, a metastatic cancer.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study in the field of cancer gives very effective result by the elucidation such as the reactions in development and the living body of the superior therapeutic drug now. However, in the immune field against cancer which I assumed the center including the diet cure, it is not the limit. It is alkaline, and, for the self-increase of the cancer cell, cancer cell in itself keeps the inside by using a pump in various cell membranes. And neighboring acidization advances by a proton and the lactic acid which I exhausted, and making it it produces the meeting of the inflammatory cell and the increase of the film mainly on the basement membrane. In addition, it is important to the growth factor for the increase of the cancer cell, and transforming growth factor-beta 1 in particular shows the strong increase restraint action for the epithelium system cell and attracts attention as one of the cancer inhibitors.
Actually, in many cancers which I did including a hereditary non-polyposis colorectal cancer and pancreatic cancer, the gene variation of a receptor and signal molecules of transforming growth factor-beta 1 is discovered, and the deviation from 1 transforming growth factor-beta signal is thought about as one of the factors of the canceration. Furthermore, transforming growth factor-beta 1 which cancer cell in itself produces acts on the normal cell around the cancer cell, and it is becoming clear to cause the accumulation of the matrix out of the cell, a vascularization, immunosuppression and hides the possibility to promote the malignant transformation of cancer, permeation, metastasis.
We think this time to examine it how this transforming growth factor-beta 1 changes by putting a diet cure and existing cancer treatment together.
From this study, I raise the possibility of the important inhibitor in cancer more and may contribute to development of the cancer treatment by weighing it against values such as other biochemical data or tumor marker.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In before and after starting a diet cure, I really measure transforming growth factor-beta 1. I watch it how the later whole body state of the patient, X-rays and CT, image views by the MRI, drawing blood data change as outcome.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Leave the next House as a first medical examination patient in our House and intend for the case that the combination of the diet cure of our House and the existing cancer cure was started for the first time.
Key exclusion criteria
At this House first medical examination, the patient who already received anticancer agent treatment more than 3 Kool is inapplicable.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Wada.M.D. |
Organization
Clinic of KARASUMA WADA
Division name
internal medicine
Zip code
Address
538 Nijyoutonomachi-karasumaoike-noboru-tyuukyouku-kyoutoshi-kyouto
TEL
075-213-0080
wikom@yc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masashi yanaki |
Organization
Clinic of KARASUMA WADA
Division name
internal medicine
Zip code
Address
802-9tyoume-4-yotyoucity-sinnjyukuku-Tokyou
TEL
090-8804-7526
Homepage URL
http://www.karasuma-wadaclinic.com/
yanakimasashi@yahoo.co.jp
Sponsor or person
Institute
Clinic of KARASUMA WADA
Institute
Department
Personal name
Funding Source
Organization
Clinic of KARASUMA WADA
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
By a result, we submit a paper to either engines.
Management information
Registered date
| 2013 | Year | 08 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013547
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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