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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025715
Receipt No. R000028392
Scientific Title Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water
Date of disclosure of the study information 2017/01/17
Last modified on 2019/07/21

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Basic information
Public title Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water
Acronym Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water
Scientific Title Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water
Scientific Title:Acronym Observational study about the association between ovarian cancer recurrence prevention and parameter of immunity with the deep-ocean water
Region
Japan

Condition
Condition ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 I consider whether Depp Ocean Water(DOW) is effective for immunocompetence improvement after the treatment of the ovarian cancer patient.
There is a cell group taking regular immunoresponse, negative immunoresponse in the living body. When negative immunoresponse is strong, it is expected that a relapse rate after the first treatment rises, but the recurrence is more likely to be controlled when regular immunoresponse continues it. For 24 months, I include it and do the PFI in patients performed induction of remission of in the ovarian cancer first time at least with an observation period between three years. The parameter of the living body of immunity considers I change, and how it contributes to convalescence improvement by drinking DOW this time. I perform group distinction of an ovarian cancer patient and judge an effect of DOW. The main end-point assumes it a parameter (CD3.CD4.CD8.CD12.CD11b.CD19.CD16.CD56) of immunity. I do the secondary end-point with disease-free survival, all duration of survival.
Basic objectives2 Others
Basic objectives -Others Ovarian cancer recurrence protective efficacy of DOW
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Parameter (CD3.CD4.CD8.CD12.CD11b.CD19.CD16.CD56) of the host of immunity
Key secondary outcomes PFS OS

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 A group (the DOW administrated group): I drink Depp Ocean Water(DOW) 500 ml/day in normal life. I perform a study from a registration start with a period to being finished.
Interventions/Control_2 B group (control group): I drink 500 ml/day of placebo water in normal life. I perform a study from a registration start with a period to being finished.
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria We I choose the patient who does not have an exclusion item among the ovarian cancer patients whom the 80-year-old first induction of remission was got from from 50 years old that received the hospital obstetrics and gynecology department attached to the Kochi University medical department.
Key exclusion criteria 1.Person (immunosuppressive drug, adrenal cortical hormone) who takes the drug which may influence the endpoint
2.The person who needs water restrictions due to the disease including heart failure, the renal insufficiency
3.The person who participates in other clinical trials
4.One having serious complications including renal insufficiency, liver failure, the heart failure
5.One having the high blood pressure that is not controlled by medical treatment
6.One having lower limbs vein thrombosis
7.One having lower limbs lymphedema
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Nagamasa
Middle name
Last name Maeda
Organization Kochi Medical School
Division name Obstetrics and gynecology
Zip code 783-8505
Address okoh,Nannkoku,Kochi,Japan
TEL 088-880-2383
Email maedan@kochi-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Ushiwaka
Organization Kochi Medical School
Division name Obstetrics and gynecology
Zip code 783-8505
Address okoh,Nannkoku,Kochi,Japan
TEL 088-880-2383
Homepage URL
Email takashi-u@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

Funding Source
Organization Muroto, Kochi deep-ocean water functionality evaluation business
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kochi Medical School
Address Kohasu Okocyo Nangokushi Kochi
Tel 088-866-5811
Email is21@kochi-u.ac.jp

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
2017 Year 01 Month 17 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 19 Day
Date of IRB
2015 Year 03 Month 19 Day
Anticipated trial start date
2015 Year 03 Month 19 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 17 Day
Last modified on
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028392

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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