UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058060
Receipt number R000066362
Scientific Title Prediction of intravesical recurrence of bladder tumor using urine DNA
Date of disclosure of the study information 2025/07/01
Last modified on 2025/06/02 23:30:34

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Basic information

Public title

Prediction of intravesical recurrence of bladder tumor using urine DNA

Acronym

urine DNA detection of BT recurrence

Scientific Title

Prediction of intravesical recurrence of bladder tumor using urine DNA

Scientific Title:Acronym

urine DNA detection of BT recurrence

Region

Japan


Condition

Condition

non-invasive bladder tumor (urothelial cancer)

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

prediction of intravesical recurrence of bladder tumor

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to positive detection of urine DNA

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

Prevention

Type of intervention

Gene

Interventions/Control_1

measuring urine DNA and cystoscopic findings

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

patients with non-invasive urinary bladder tumor (urothelial tumor) after transurethral resection

Key exclusion criteria

Radiation history for pelvic organs

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Tomonori
Middle name
Last name Minagawa

Organization

Shinshu university

Division name

Urology

Zip code

3908621

Address

3-1-1 Asahi, Matsumoto city, Japan

TEL

0263372661

Email

minagawat@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Tomonori
Middle name
Last name Minagawa

Organization

Shinshu university

Division name

Urology

Zip code

3908621

Address

3-1-1 Asahi, Matsmoto city, Japan

TEL

0263372661

Homepage URL


Email

minagawat@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

This study was supported by the Japan Society for the Promotion of Science (JSPS) KAKENHI Early-Career Scientists JP18K16292 (to Y.H.)

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

Yamanashi Prefectural Central Hospital

Address

1-1-1 Fujimi, Kofu city, Japan

Tel

055-253-7111

Email

hirotsu-bdyu@ych.pref.yamanashi.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 07 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

14

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

2017 Year 12 Month 01 Day

Date of IRB

2018 Year 01 Month 01 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2025 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

2025 Year 06 Month 02 Day

Last modified on

2025 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066362