UMIN-CTR Clinical Trial

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
Email	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/
Email	yanakimasashi@yahoo.co.jp

Sponsor
Institute	Clinic of KARASUMA WADA
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013547

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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