UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021903 |
|---|---|
| Receipt number | R000024761 |
| Scientific Title | Identifying of index cancer among multiple cancer foci by methylation analysis using the ex vivo prostate needle biopsy from prostatectomy specimen |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/10/18 17:33:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Identifying of index cancer among multiple cancer foci by methylation analysis using the ex vivo prostate needle biopsy from prostatectomy specimen
Acronym
Identifying of index cancer by the prostate needle biopsy
Scientific Title
Identifying of index cancer among multiple cancer foci by methylation analysis using the ex vivo prostate needle biopsy from prostatectomy specimen
Scientific Title:Acronym
Identifying of index cancer by the prostate needle biopsy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify the index cancer which determine the patient prognosis among the multiple prostate cancer foci with methylation analysis using an ex vivo needle biopsy specimens to compare between prostate normal tissue and prostate cancer tissue
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
To identify the index cancer which determine the patient prognosis among the multiple prostate cancer foci with methylation analysis using ex vivo needle biopsy specimens to compare between prostate normal tissue and prostate cancer tissue
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
Methylation analysis of prostate normal tissue and cancer tissue from multiple cancer foci, which are taken from ex vivo prostatectomy specimens by needle biopsy technique
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
Inclusion criteria:
1) The patients who had histologically-confirmed prostate adenocarcinoma, agreed to undergo radical prostatectomy.
2) The patients had MR-visible prostate cancer lesion, confirmed by MRUS fusion biopsy.
3) The patients signed by themselves the informed consent document after understanding this study.
Key exclusion criteria
Exclusion criteria:.
1) Prior or concurrent chemotherapy or androgen deprivation therapy for the prostate cancer.
2) Prior radiotherapy to the prostate or lower pelvis
3) Concurrent systemic steroids therapy for different disease
4) Unsuitable for participant due to mental disorder
5) The attending physician has determined inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Ukimura |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
Kajiicho465 Kamigyoku Kyoto
TEL
075-251-5595
uro@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakatsu Oishi |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
Kajiicho465 Kamigyoku Kyoto
TEL
075-251-5595
Homepage URL
uro@koto.kpu-m.ac.jp
Sponsor or person
Institute
The department of Urology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
The department of Urology, Kyoto Prefectural University of 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
| 2016 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 14 | Day |
Last modified on
| 2019 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024761
