UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035712 |
|---|---|
| Receipt number | R000040650 |
| Scientific Title | Bladder cancer prospective cohort study on high-risk non-muscle invasive cancer after photodynamic diagnosis-assisted transurethral resection of the bladder tumor(BRIGHT study) |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2025/07/02 19:26:42 |
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Basic information
Public title
Bladder cancer prospective cohort study on high-risk non-muscle invasive cancer after photodynamic diagnosis-assisted transurethral resection of the bladder tumor(BRIGHT study)
Acronym
BRIGHT study
Scientific Title
Bladder cancer prospective cohort study on high-risk non-muscle invasive cancer after photodynamic diagnosis-assisted transurethral resection of the bladder tumor(BRIGHT study)
Scientific Title:Acronym
BRIGHT study
Region
| Japan |
Condition
Condition
non-muscle invasive bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of first PDD-TUR for high risk non-muscle invasive bladder cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor residual rate
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 and Female
Key inclusion criteria
1)Patients with first PDD-TUR
2)Patients with high risk Non-muscle Invasive Bladder Cancer(NMIBC)
3)Patients with 2nd TURBT within two month after first PDD-TUR
4)Patients with age between 20 years and under 90 year
5)Patients with ECOG Performance Status of 0-1
6)Patients with own disease information
7)Patients can provide written informed consent for study participation.
Key exclusion criteria
1)Patients with incomplete resection on first PDD-TUR
2)Patients with pT2 or Extensive CIS
3)Patients with previously enrolled in this study
4)Patients determined to be ineligible for this clinical study by research attending physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideyasu |
| Middle name | |
| Last name | Matsuyama |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Urology
Zip code
753-8511
Address
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2275
hidde@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Yano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Urology
Zip code
753-8511
Address
1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2275
Homepage URL
syano@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
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
Institutional Review Board Yamaguchi University Hospital
Address
1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
Tel
0836-22-2428
clin_res@yamaguchi-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
山口大学医学部附属病院（山口県）
高知大学医学部附属病院（高知県）
奈良県立医科大学付属病院（奈良県）
埼玉医科大学国際医療センター（埼玉県）
浜松医科大学医学部附属病院（静岡県）
大阪医科大学付属病院（大阪府）
筑波大学付属病院（茨城県）
神戸市立医療センター（兵庫県）
東京大学医学部附属病院（東京都）
金沢大学付属病院（石川県）
弘前大学医学部付属病院（青森県）
山梨大学医学部付属病院（山梨県）
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/iju.14854
Number of participants that the trial has enrolled
177
Results
Analyses included 177 photodynamic diagnosis cases and 306 white light cases. Residual tumor rates were 25.7 percent and 47.3 percent. In photodynamic diagnosis, rates were higher with smoking history, multiple tumors, and pT1 or pTis. Patients with a total risk score of 1 or less had lower residual tumor rates than those with 2 or more, at 8.3 versus 33.3 percent, odds ratio 5.46.
Results date posted
| 2025 | Year | 07 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 15 | Day |
Baseline Characteristics
PDD TURBT was conducted with radical curative intent at participating study institutions from December 2018 to December 2020. Patients aged 20 years or older and younger than 90 years with a histopathological diagnosis of high risk NMIBC such as high grade UC pT1 or concurrent CIS who wished to participate in the study were included. We included patients who underwent TURBT under white light and were diagnosed with high risk NMIBC followed by a second TURBT within 2 months after the first visit and these patients were retrospectively included as participants from January 2006 to November 2016. Among the 188 cases registered in the PDD group 177 were included in the analyses after excluding 11 ineligible cases. For historical data evaluation 306 of the 313 cases registered in the white light group were analyzed after excluding seven ineligible cases.
Participant flow
Patients diagnosed with NMIBC who consented to the implementation of PDD TURBT were orally administered 5 ALA hydrochloride at 20 milligrams per kilogram dissolved in distilled water 3 hours before the insertion of the cystoscope with a range of 2 to 4 hours. Generally the second TURBT under white light was performed within 2 months of the first TURBT. The second TURBT involved resectioning the bottom of the tumor and the surrounding mucosa centering on the previously resected area. Subsequently intravesical recurrence was evaluated over 2 years of regular medical examinations with urinary cytology and cystoscopy every 3 months performed as a daily clinical practice. Postoperative adjuvant therapy was mainly intravesical bacillus Calmette Guerin infusion therapy according to the bladder cancer clinical practice guidelines.
Adverse events
Adverse reactions at the time of the PDD-TURBT were as follows: elevated AST or ALT levels, 12 cases (6.3%); gastrointestinal symptoms, five cases (2.6%) (all grade 1); and severe hypotension, seven cases (3.1%) (grade 3). However, no severe, life-threatening adverse reactions were observed.
Outcome measures
The primary endpoint was the residual tumor rate at the time of the second TURBT, which was evaluated by histopathological analysis of the tissue around the tumor and the bottom of the tumor using a WL source.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2019 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040650
