UMIN-ICDS Clinical Trial

Public title

A Comparative Study of Methods for Detecting Urothelial Cancer Using Urine Cells

Acronym

A Comparative Study of Urine Cell-Based Methods for Detecting Urothelial Cancer

Scientific Title

Comparative Evaluation of the Diagnostic Performance of Conventional Urine Cytology and Ex Vivo Prepared Urine Cytology for the Detection of Urothelial Carcinoma

Scientific Title:Acronym

Diagnostic Performance Comparison Study of Ex Vivo Prepared Urine Cytology

Region

Japan

Condition

Urothelial carcinoma or suspected urothelial carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study will enroll patients with suspected urothelial carcinoma and patients with other urological diseases, including prostate cancer, renal cancer, benign prostatic hyperplasia, and urinary stones, all of whom present with microscopic or gross hematuria. We will compare the diagnostic performance of conventional urine cytology using spontaneously voided urine with that of ex vivo prepared urine cytology, which is generated by applying a proprietary optimized preparation procedure to rare exfoliated cells in voided urine. This study is designed as a Validation Phase study to demonstrate the clinical validity of this technology in a real-world hematuria cohort, using the protocol established in the preceding Development Phase without any modification. Cytological assessment will be conducted by evaluators who are fully blinded to clinical information. The objective is to confirm the usefulness of this method as a novel, minimally invasive pathological diagnostic system for urothelial carcinoma.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Comparison of the diagnostic sensitivity of conventional urine cytology and ex vivo prepared urine cytology using a strictly defined gold standard* as the reference standard
* To ensure the validity of this diagnostic accuracy study, the reference standard used to determine the true disease status, namely the gold standard, is strictly predefined as follows:

Cancer group: True-positive cases are defined as those in which a definitive diagnosis of urothelial carcinoma is established by pathological evaluation of tissue specimens obtained by surgery or biopsy.
Non-cancer group: True-negative cases are defined as those in which no findings suggestive of urothelial carcinoma are identified through standard clinical evaluations, including transurethral endoscopy, surgery, biopsy, CT/MRI, ultrasonography, or other routine diagnostic work-up, and in which no new onset or diagnosis of urothelial carcinoma is observed during at least 6 months of clinical follow-up. When cases are classified as non-cancer based solely on imaging findings, it is mandatory that MRI shows no intravesical lesion and that ultrasonography shows no findings suggestive of urothelial carcinoma, such as upper urinary tract obstruction or hydronephrosis.

Key secondary outcomes

1.Comparison of the specificity of the two tests using the gold standard as the reference standard
2.Determination of the optimal cutoff value based on ROC analysis and comparison of the AUC
3.Comparison of diagnostic performance for bladder cancer and upper tract urothelial carcinoma, respectively
4.Comparison of diagnostic performance according to the pathological grade of urothelial carcinoma, classified as low-grade or high-grade
5.Evaluation of the success rate of novel specimen preparation from spontaneously voided urine

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria will be included in this study:
1.Patients who are 18 years of age or older at the time of consent, regardless of sex.
2.Patients in whom gross or microscopic hematuria has been confirmed by recent examination.
3.Patients who are scheduled to undergo imaging studies, transurethral endoscopic evaluation and/or procedures, or surgery for the evaluation or treatment of urothelial carcinoma.
4.Patients who have received sufficient explanation regarding participation in this study, have fully understood the study, and have provided written informed consent of their own free will.
5.Patients who have been informed of their disease name and clinical condition, have the capacity to provide consent, and have provided written informed consent.

Key exclusion criteria

Patients who meet any of the following criteria will not be included in this study:

1.Patients who are considered unable to provide informed consent due to dementia, psychiatric disorders, or other conditions.
2.Patients with metastatic urothelial carcinoma who were diagnosed based only on urine cytology and imaging studies, without pathological confirmation.
3.Patients who are otherwise judged by the principal investigator to be inappropriate for

Target sample size

100

Name of lead principal investigator

1st name	Takashi
Middle name
Last name	Yoshida

Organization

Kansai Medical University

Division name

Department of Urology and Andrology

Zip code

573-1010

Address

2-5-1 Shinmachi, Hirakata, Osaka

TEL

0728042083

Email

yoshida.tks@kmu.ac.jp

Name of contact person

1st name	Takashi
Middle name
Last name	Yoshida

Organization

Kansai Medical University

Division name

Department of Urology and Andrology

Zip code

573-1010

Address

2-5-1 Shinmachi, Hirakata, Osaka

TEL

0728042083

Homepage URL

Email

yoshida.tks@kmu.ac.jp

Institute

Kansai Medical University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kansai Medical University Hospital Research Ethics Committee

Address

2-5-1 Shinmachi, Hirakata, Osaka

Tel

(072) 804-2083

Email

rinri@kmu.ac.jp

Secondary IDs

YES

Study ID_1

2026099

Org. issuing International ID_1

Kansai Medical University Hospital Research Ethics

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

08

Month

05

Day

Date of IRB

2026

Year

08

Month

05

Day

Anticipated trial start date

2026

Year

08

Month

05

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a prospective observational diagnostic accuracy study in patients with hematuria. Using urine samples obtained from the same patients, urine cytology will be performed using the conventional method and an ex vivo preparation method, and the diagnostic performance, particularly sensitivity, will be compared between the two methods. This study involves no intervention or invasive procedures, and cytological evaluation will be performed in a blinded manner.

Registered date

2026

Year

09

Month

12

Day

Last modified on

2026

Year

09

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070813