UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056220 |
|---|---|
| Receipt number | R000064235 |
| Scientific Title | Japan Urolithiasis Survey, 8th Edition |
| Date of disclosure of the study information | 2024/11/21 |
| Last modified on | 2025/11/22 09:09:04 |
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Basic information
Public title
Japan Urolithiasis Survey, 8th Edition
Acronym
JUS-8
Scientific Title
Japan Urolithiasis Survey, 8th Edition
Scientific Title:Acronym
JUS-8
Region
| Japan |
Condition
Condition
Urolithiasis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The National Epidemiological Surveillance of Urolithiasis in Japan has been conducted every 10 years since 1955. The 7th National Epidemiological Survey of Urolithiasis was conducted in 2015, following the hospital survey method and further improving the collection of individual data. Ten years after the previous survey, the 8th National Epidemiological Survey of Urolithiasis will be conducted in 2025 to observe changes in the epidemiology of Urolithiasis over the past decade.
Basic objectives2
Others
Basic objectives -Others
The Japanese National Epidemiological Survey of Urolithiasis has been conducted every 10 years since 1955, with the Japan Urolithiasis Society leading it since 2005. In the 2015 survey, 301 institutions participated, enrolling 79,003 cases in the total survey and 21,341 cases in the individual survey.
The current survey follows the same methods:
Total Survey: Retrospective collection of data on urolithiasis cases by sex, age, site, and history of stone formation (initial/recurrent) to determine the incidence in the Japanese population.
Individual Survey: Prospective collection of detailed data from consenting patients, including background, history of urolithiasis, comorbidities, diagnostic methods, blood and urine analysis, stone characteristics, and treatment methods.
The goal is to gather comprehensive and updated information on the prevalence, patient backgrounds, and clinical characteristics of urolithiasis in Japan to inform future treatment strategies.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of urolithiasis by sex, age, and site (per 100,000) in Japan
Key secondary outcomes
Annual incidence of first upper and lower urolithiasis (per 100,000)
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have a urinary tract stone in their body at any time between January 1 and December 31, 2025 (the diagnosis of stone is determined by the attending physician). The diagnosis of stone diagnosis is determined by the attending physician. Even if the presence of a stone is not obvious or the stone is considered to have already been expelled by the patient, if the attending physician determines that a stone is (or was) present based on clinical symptoms and laboratory findings, the patient is considered to have a urinary tract stone.
Patients who do not meet the following exclusion criteria
Key exclusion criteria
Patients with urinary tract stones on or before December 31, 2024, who are being followed up during the year 2025 without stone migration.
Patients who refused to participate in this study
Other patients who are deemed unsuitable by the principal investigator or subinvestigator.
Target sample size
80000
Research contact person
Name of lead principal investigator
| 1st name | Katsuhito |
| Middle name | |
| Last name | Miyazawa |
Organization
Kanazawa Medical University
Division name
Urology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada-machi, Kahoku, Ishikawa, Japan
TEL
+81-76-218-8145
miyazawa@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Iguchi |
Organization
Kanazawa Medical University
Division name
Urology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada-machi, Kahoku, Ishikawa, Japan
TEL
+81-76-218-8145
Homepage URL
taro@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society on Urolithiasis Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Osaka University Hospital
Address
4F, Advanced Medical Innovation Center Building, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
北海道医療センター/北海道大学病院/八戸平和病院/仙台赤十字病院/秋田厚生医療セン
ター/太田記念病院/国際医療福祉大学病院/水戸医療センター/水戸済生会総合病院/上
尾中央総合病院/さいたま赤十字病院/亀田総合病院/順天堂大学浦安病院/千葉市立青葉
病院/千葉大学/千葉労災病院/東京慈恵会医科大学附属柏病院/千葉医療センター/公立
昭和病院/九段坂病院/東京医科歯科大学病院/東京慈恵会医科大学附属第三病院/東京慈
恵会医科大学/東京都立大塚病院/東京都立小児総合医療センター/東京臨海病院/四谷メ
ディカルキューブ/川崎市立多摩病院/済生会横浜市東部病院/横浜市立大学附属病院/長
谷川病院/JCHO 金沢病院/福井勝山総合病院/福井大学医学部/信州大学/豊川市民病
院/豊田厚生病院/名古屋市立大学/名古屋大学/東近江総合医療センター/京都大学/医仁
会武田総合病院/吹田徳洲会病院/大阪労災病院/大手前病院/堺市立総合医療セン
ター/住友病院/ベルランド総合病院/箕面市立病院/神戸市立医療センター中央市民病
院/和歌山県立医科大学/島根大学/倉敷成人病センター/岡山大学病院/川崎医科大学附
属病院/岡山医療センター/広島西医療センター/香川県立中央病院/大樹会総合病
院/KKR 高松病院/愛媛大学/市立八幡浜総合病院/原三信病院/福岡和白病院/福岡青洲会
病院/長崎大学/熊本大学/宮崎県立延岡病院/今村総合病院/公立富岡総合病院/埼玉医大
総合医療センター/北里研究所病院/杏林大学/順天堂大学順天堂医院/帝京大学医学部附
属病院/東京大学医科学研究所附属病院/東京西徳洲会病院/JR 東京総合病院/横須賀市
立うわまち病院/金沢大学附属病院/中濃厚生病院/羽島市民病院/焼津市立総合病院/蒲
郡市民病院/大同病院/名古屋市立大学附属西部医療センター/日赤愛知医療センター名
古屋第二病院/藤田医科大学/長浜市立湖北病院/岸和田徳洲会病院/枚方公済病院/市立
池田病院/高槻病院/大阪はびきの医療センター/神戸市立西神戸医療センター/米子医療
センター/県立広島病院/広島大学/徳島県立中央病院/徳島大学/福岡赤十字病院/熊本医
療センター/大分市医師会立アルメイダ病院/にいむら病院/南部徳洲会病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 21 | 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
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observation and survey items
(1) Total survey
In this study, data will be collected from medical records by sex, age (in 10-year intervals), site, and history of stone formation (initial/recurrent).
(2) Individual survey
In this study, data will be collected by self-administered questionnaires and transcription of medical records and laboratory results. Data (1)-(3) will be collected by a self-administered questionnaire (to be administered after obtaining consent at the patient's first visit: Appendix 3), and data (4)-(7) will be collected by transcription of the medical record and laboratory test results.
Patient background: date of birth, age, gender, height (cm), weight (kg), presence of stone symptoms
(2) Stone history: history of stone formation (first occurrence/recurrence), age at first occurrence (in case of recurrence), number of times stone formation has occurred
Comorbidities: hypertension, diabetes mellitus (including exercise therapy), dyslipidemia (hyperlipidemia, high cholesterol, high triglycerides, etc.), gout, urinary stagnation (hydronephrosis, etc.), urinary tract infection, osteoporosis, chronic kidney disease, bedridden (more than 1 month), primary hyperparathyroidism, renal tubular acidosis, intestinal diseases (short bowel syndrome, Crohn's disease, ulcerative heart disease) Intestinal diseases (short bowel syndrome, Crohn's disease, ulcerative colitis, etc.)
(iv) Diagnosis: method of diagnosis, main site of stone formation, number of stones
(5) Blood, urine and biochemical data: hypercalcemia, hyperuricemia, hypercalciuria, hyperuricosuria, cystinuria, hyperoxaluria, hypocitrateuria
(6) Stone formation information: results of stone analysis, presence or absence of stone-inducing drugs, and
(7) Treatment: presence/absence of stone-promoting drugs, primary treatment, and drugs for prevention of recurrence.
Management information
Registered date
| 2024 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064235
