UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029750 |
|---|---|
| Receipt number | R000033989 |
| Scientific Title | Diagnosis of prostate cancer by carbon 11-choline positron emission tomography/computed tomography |
| Date of disclosure of the study information | 2017/10/29 |
| Last modified on | 2023/04/26 14:06:34 |
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Basic information
Public title
Diagnosis of prostate cancer by carbon 11-choline positron emission tomography/computed tomography
Acronym
Choline PET/CT for prostate cancer
Scientific Title
Diagnosis of prostate cancer by carbon 11-choline positron emission tomography/computed tomography
Scientific Title:Acronym
Choline PET/CT for prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate sensitivity and specificity of choline PET/CT for prostate cancer in several clinical stages (clinical settings), comparing with conventional imaging modalities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensitivity and specificity
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Cases with prostate cancer which is confirmed histologically
Cases in which prostate cancer is highly suspected clinically
Key exclusion criteria
Cases with severe liver dysfunction and/or renal dysfunction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuko Takahashi |
Organization
National center for global health and medicine
Division name
Urology
Zip code
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
TEL
03-3202-7181
tatsuko@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Takahashi |
Organization
National center for global health and medicine
Division name
Urology
Zip code
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
panchoatsuko@yahoo.co.jp
Sponsor or person
Institute
National center for global health and medicine
Institute
Department
Personal name
Funding Source
Organization
National center for global health and medicine
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
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 | 10 | Month | 29 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Lesions detected by choline PET/CT will be re-evaluated by conventional imagin modalities including CT scan and bone scintigram.
Management information
Registered date
| 2017 | Year | 10 | Month | 29 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033989
