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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004087
Receipt No. R000004924
Scientific Title Bone loss after neoadjuvant chemotherapy and total cystectomy for muscle invasive bladder cancer
Date of disclosure of the study information 2010/08/23
Last modified on 2015/02/24

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Basic information
Public title Bone loss after neoadjuvant chemotherapy and total cystectomy for muscle invasive bladder cancer
Acronym Bone loss after neoadjuvant chemotherapy and total cystectomy for muscle invasive bladder cancer
Scientific Title Bone loss after neoadjuvant chemotherapy and total cystectomy for muscle invasive bladder cancer
Scientific Title:Acronym Bone loss after neoadjuvant chemotherapy and total cystectomy for muscle invasive bladder cancer
Region
Japan

Condition
Condition Muscle invasive bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Neoadjuvant chemotherapy and total cystectomy may induce bone loss.
Basic objectives2 Others
Basic objectives -Others Assessment of bone loss as an adverse event in standard therapy for muscle invasive bladder cancer
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Bone mineral density of lumber spine
Key secondary outcomes Serum BAP and NTx

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 Aquisition of informed consent
Muscle invasive bladder cancer (>=T2)
No distant metastasis (M0)
Performance status 0-2 of ECOG
No liver impairment defined as AST, ALT and T-Bil levels less than 1.5 times as high as institutinal limit, no renal impairment defined as Cr < 2.0 mg/dl, and no hematological abnormalities defined as WBC > 3000000/ml, Hb > 8.0 g/dl, Plts > 100000000/ml
Key exclusion criteria Patients physicians in charge think this study will harm
Active double cancer
All patients physicians in charge judged to be ineligible
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Mizokami
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Integrative Cancer Therapy and Urology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2393
Email mizokami@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Mizokami
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Integrative Cancer Therapy and Urology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2393
Homepage URL
Email mizokami@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Science, Department of Integrative Cancer Therapy and Urology
Institute
Department

Funding Source
Organization None
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 金沢大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 23 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
2009 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We examine prospectively whether neoadjuvant chemotherapy and total cystectomy as an standard therapy for muscle invasive bladder cancer induces bone loss, measuring bone mireral density of lumber spine.

Management information
Registered date
2010 Year 08 Month 23 Day
Last modified on
2015 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004924

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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