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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036126
Receipt No. R000041155
Scientific Title Effects of alkalization therapy in metastatic or recurrent pancreatic cancer: a case-control study
Date of disclosure of the study information 2019/03/11
Last modified on 2019/03/12

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Basic information
Public title Effects of alkalization therapy in metastatic or recurrent pancreatic cancer: a case-control study
Acronym Effects of alkalization therapy in metastatic or recurrent pancreatic cancer
Scientific Title Effects of alkalization therapy in metastatic or recurrent pancreatic cancer: a case-control study
Scientific Title:Acronym Effects of alkalization therapy in metastatic or recurrent pancreatic cancer
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to investigate the effects of alkalization therapy consisting of alkaline diet and bicarbonate compared with the control group.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival (OS)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Intervention group: Metastatic or recurrent pancreatic cancer patients who treated with alkalization therapy consisting of alkaline diet and bicarbonate
Control group: Metastatic or recurrent pancreatic cancer patients who did not receive alkalization therapy
Key exclusion criteria Patients who refused to participate the study by opt-out.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Wada
Organization Karasuma Wada Clinic
Division name Oncology
Zip code 604-0845
Address Yasaka Karasuma-oike Building 2F, Nijodencho 538, Karasuma-dori Oike Noboru, Nakagyo-ku, Kyoto 604-0845, Japan
TEL 075-213-0080
Email wadah@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Reo
Middle name
Last name Hamaguchi
Organization Karasuma Wada Clinic
Division name Oncology
Zip code 604-0845
Address Nijodencho 538, Karasuma-dori Oike Noboru, Nakagyo-ku, Kyoto, Japan
TEL 075-213-0080
Homepage URL
Email reo-h@nifty.com

Sponsor
Institute Karasuma Wada Clinic
Institute
Department

Funding Source
Organization Karasuma Wada Clinic
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 Ethics Committe, Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital
Address Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501
Tel 075-753-4683
Email ethcom@kuhp.kyoto-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
2019 Year 03 Month 11 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 26 Day
Date of IRB
2018 Year 10 Month 26 Day
Anticipated trial start date
2018 Year 12 Month 31 Day
Last follow-up date
2019 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study is case-control study that compare alkalization therapy group (Karasuma Wada Clinic) with control group (Kyoto University).

Management information
Registered date
2019 Year 03 Month 08 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041155

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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