UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004087 |
|---|---|
| Receipt number | 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 11:15:43 |
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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
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
mizokami@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science, Department of Integrative Cancer Therapy and Urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004924
