UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011585
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.