UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059043 |
|---|---|
| Receipt number | R000067538 |
| Scientific Title | Research on Novel Biomarkers and Therapeutic Target Molecules for Urological Cancers |
| Date of disclosure of the study information | 2025/09/15 |
| Last modified on | 2025/09/10 11:49:42 |
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Basic information
Public title
Research on Novel Biomarkers and Therapeutic Target Molecules for Urological Cancers
Acronym
BRIGHTstudy
Scientific Title
Research on Novel Biomarkers and Therapeutic Target Molecules for Urological Cancers
Scientific Title:Acronym
Research on Novel Biomarkers and Therapeutic Target Molecules for Urological Cancers
Region
| Japan |
Condition
Condition
Genitourinary Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Urological cancers, including renal cell carcinoma, urothelial carcinoma of the renal pelvis and bladder, testicular cancer, and prostate cancer, are generally considered to have more favorable prognoses compared with many other malignancies. However, for patients who are not candidates for surgery or who experience disease recurrence, the effectiveness of chemotherapy remains limited. In this context, research efforts have focused on identifying molecular markers useful for early diagnosis and prediction of treatment resistance.
Our group has previously developed antibodies that can be applied to diagnosis and research, and we have demonstrated their potential utility as novel biomarkers. Building on these achievements, the present study aims to explore molecular targets associated with early detection and prognosis in renal cell carcinoma, urothelial carcinoma of the renal pelvis and bladder, testicular cancer, and prostate cancer. Furthermore, we will develop antibodies against these molecules to establish new diagnostic methods.
Through this research, we aim:
To contribute to improved patient outcomes by facilitating the early detection of surgically treatable cancers.
To enable personalized treatment selection by developing prognostic biomarkers that predict clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Search for biomarkers effective for diagnosis and treatment
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 and Female
Key inclusion criteria
Patients with genitourinary cancer
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Chiba |
| Middle name | |
| Last name | Hideki |
Organization
Fukushima Medical University
Division name
Department of Basic Pathology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
0245471111
onagi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Hoshi |
Organization
Fukushima Medical University
Division name
Department of Urology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
0245471316
Homepage URL
uro-hosi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
Tel
0245471111
fmucrb@fmu.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
| 2025 | Year | 09 | Month | 15 | 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 | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067538
