UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045726 |
|---|---|
| Receipt number | R000052099 |
| Scientific Title | Identification of novel biomarkers for diagnosis and treatment of bladder cancer using urinary exosomes |
| Date of disclosure of the study information | 2021/10/12 |
| Last modified on | 2022/10/14 12:09:06 |
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Basic information
Public title
Research to find new indicators for diagnosis and treatment of bladder cancer using exosomes in urine
Acronym
Diagnosis and treatment of bladder cancer
Scientific Title
Identification of novel biomarkers for diagnosis and treatment of bladder cancer using urinary exosomes
Scientific Title:Acronym
Diagnosis and treatment of bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether bladder cancer-specific exosomes in urine are useful as diagnostic and prognostic markers for bladder cancer and to explore how they are involved in the growth and progression of bladder cancer. Next, we will discover miRNAs that inhibit the secretion of exosomes specific to bladder cancer, i.e., miRNAs that inhibit the secretion of exosomes by cancer cells, analyze their effects on the function of bladder cancer, and develop a novel intravesical injection therapy using these miRNAs.
Basic objectives2
Others
Basic objectives -Others
diagnosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exosomes extracted from urine samples will be analyzed using the ExoScreen method to evaluate the difference in expression of specific exosomes between bladder cancer patients and non-cancer patients.
Key secondary outcomes
In immunohistochemical staining using surgical specimens, the expression of target substances in cancer tissues, mainly nucleic acids and proteins including miRNAs, will be compared with the expression in non-cancerous tissues.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
1) Urine specimen
In patients with bladder cancer, urine should be collected at the time of diagnosis, when postoperative recurrence is confirmed, before and after surgery during hospitalization for cancer resection, and before and after chemotherapy, in addition to the 3-6 month frequency during outpatient visits.
There is no guideline for the timing of urine collection except for patients with bladder cancer, and urine should be collected only once after consent.
2) Surgical specimens
Of the histopathological specimens of bladder tumors obtained by transurethral resection of bladder tumor or total cystectomy, the remaining surplus specimens used for diagnosis are used.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are able to collect urine
1) Patients with bladder cancer: diagnosed by various imaging tests, urine cytology, and cystoscopy
2) Patients with benign diseases not accompanied by infection: benign prostatic hyperplasia, ureteral stones, etc.
3) Normal patients: Patients with no obvious organic urological disease such as kidney transplant donors
4) Patients with urinary tract infection: pyelonephritis, cystitis, prostatitis
5) Patients with urological cancer other than bladder cancer: prostate cancer, testicular cancer, renal cell carcinoma
Key exclusion criteria
1) Patients undergoing treatment for malignant diseases in other departments
2) Patients who are judged by the principal investigator to be unsuitable as subjects.
3) Patients who have expressed their intention not to cooperate in this study.
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | Hayakawa |
Organization
St.Marianna University School of Medicine
Division name
Department of Urology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL
+81-44-977-8111
nozomi.hayakawa@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Usuba |
Organization
St.Marianna University School of Medicine
Division name
Department of Urology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL
+81-44-977-8111
Homepage URL
https://www.marianna-u.ac.jp/hospital/
w2usuba@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee, St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
Tel
+81-44-977-8111
k-sienbu.mail@marianna-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 | 10 | Month | 12 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 10 | Month | 12 | Day |
Last modified on
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052099
