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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023032
Receipt No. R000026544
Scientific Title The exploration for the palliative efficacy of Hochu-ekkitou in genitourinary cancer patient
Date of disclosure of the study information 2016/07/20
Last modified on 2016/07/05

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Basic information
Public title The exploration for the palliative efficacy of Hochu-ekkitou in genitourinary cancer patient
Acronym HOPE Study
Scientific Title The exploration for the palliative efficacy of Hochu-ekkitou in genitourinary cancer patient
Scientific Title:Acronym HOPE Study
Region
Japan

Condition
Condition metastatic genitourinary cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The exploration for the palliative efficacy of Hochu-ekkitou in metastatic genitourinary cancer patient who were received at least one anti cancer therapeutic agent.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL
Measuring IL-6, IL-1 beta, TNF alpha as the cachexia marker
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Metastatic genitourinary cancer patients who were received at least one anticancer agent
2)Patients planed the next new anticancer agents
3)Over 20-year old patients
4)ECOG PS 0-1
5)Patients who accept the enrollment in the study
6) Patients who have proper bone marrow, renal, and liver function
Key exclusion criteria Patients who do not accept the enrollment in the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Anai
Organization Nara Medical University
Division name Dept. of Urology
Zip code
Address 840 Shijo-Cho Kashihara-shi
TEL 0744-22-3051
Email sanai@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Anai
Organization Nara Medical University
Division name Dept. of Urology
Zip code
Address 840 Shijo-Cho Kashihara-shi
TEL 0744-22-3051
Homepage URL
Email sanai@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
Organization
Division
Category of Funding Organization Other
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
2016 Year 07 Month 20 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information QOL
IL-6, IL-1 beta, TNF-alpha

Management information
Registered date
2016 Year 07 Month 05 Day
Last modified on
2016 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026544

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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