UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044918 |
|---|---|
| Receipt number | R000050767 |
| Scientific Title | An observational study to develop pathological screening method for predicting genetic alteration in prostate cancer |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2022/02/04 10:17:43 |
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Basic information
Public title
An observational study to develop pathological screening method for predicting genetic alteration in prostate cancer
Acronym
APPP study
Scientific Title
An observational study to develop pathological screening method for predicting genetic alteration in prostate cancer
Scientific Title:Acronym
APPP study
Region
| Japan |
Condition
Condition
Prostate cancner
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Clarify the relationship between IDC-P and HRRm or tumor suppressor genes
Basic objectives2
Others
Basic objectives -Others
Prognosis with or without IDC-P and HRRm in mHSPC patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between IDC-P and HRRm
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
Key inclusion criteria
mHSPC (Latitude high risk)
Key exclusion criteria
double cancer
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Hospital
Division name
Department of Urology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
+81527442984
mk-kato@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Hospital
Division name
Department of Urology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
+81527442984
Homepage URL
mk-kato@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Astra Zeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University ethic committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
+81527412479
center@med.nagoya-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
| 2021 | Year | 08 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The positive rate of HRRm by IDC-P status (positive/negative), Clinical outcomes (time to CRPC, radiographic progression free survival and overall survival) by IDC-P status and/or HRRm status.
Management information
Registered date
| 2021 | Year | 07 | Month | 20 | Day |
Last modified on
| 2022 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050767
