Ureteral CalculiUROLITH-POLYPNCT07559721
Risk Factors and Predictive Model for Inflammatory Polyps in Ureteral Stones
An observational study of Ureteral Calculi, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This is an observational studyincluding an internal retrospectivedevelopment cohort, an internalprospective temporal validation cohortand two external validation cohorts fromtwo independent external centers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ureteral Calculi
- How many people
- 1,351 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 7 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: The study population includes adult patients with ureteral calculi who underwent ureteroscopic treatment. The retrospective patients were enrolled at the First Hospital of Jilin University between 2018 and 2025. The prospective cohort consecutively enrolled new patients for validation between April 7 and September 7, 2026. Two additional independent external centers retrospectively collected consecutive eligible patients with ureteral calculi for external validation.
Who may be able to join
- Patients aged 18 years or older undergoing ureteroscopic surgery for ureteral calculi at the First Hospital of Jilin University.
- Complete clinical and imaging data available.
Who cannot join
- Patients with bilateral ureteral calculi.
- Patients with preoperative nephrostomy or indwelling ureteral stent.
- Patients with a history of ureteral or bladder cancer.
- Patients with congenital ureteral anomalies or previous ureteral surgery.
- Patients with severe coagulation disorders or contraindications to ureteroscopy.
- Patients unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors and Development of a Predictive Model for Stone-Associated Inflammatory Ureteral Polyps: A Retrospective Cohort Study With Prospective Validation
This is an observational studyincluding an internal retrospectivedevelopment cohort, an internalprospective temporal validation cohortand two external validation cohorts fromtwo independent external centers. Thestudy aims to identify independent riskfactors for inflammatory ureteral polypsin patients with ureteral calculi anddevelop a preoperative predictive model
Retrospective clinical and radiologicaldata were extracted from eligiblepatients treated from January 1, 2018to December 31, 2025 (n=874). Theprospective cohort consecutivelyenrolled participants from April 72026, to September 7, 2026 (n=162)Consecutive eligible patients from twoexternal centers were included forexternal validation (n=139 and n=176).The primary outcome is theintraoperative diagnosis of inflammatoryureteral polyps
Read the detailed description
This is a mixedretrospective-prospective observationalcohort study. The internal retrospectivedevelopment cohort (n=874) was fullyenrolled from January 1, 2018, toDecember 31, 2025, and was further splitinto a 70% training set and a 30%model-selection holdout set. Theinternal prospective temporal validationcohort consecutively enrolled eligibleparticipants from April 7, 2026, toSeptember 7, 2026 (n=162). Twoindependent external validation cohortsfrom two separate centers includedconsecutively enrolled patients withureteral calculi (n=139 and n=176)Preoperative clinical and radiologicaldata were collected to screenindependent risk factors and build apreoperative predictive model forinflammatory ureteral polyps. Theprimary endpoint was intraoperativediagnosis of inflammatory ureteralpolyps.
- Conditions
- Ureteral Calculi
- Medical subject headings
- Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Model development cohort, | Model development cohort, including aninternal retrospective developmentsubset (Jan 1, 2018-Dec 31, 2025, n=874split into training and holdout set) andan internal prospective temporalvalidation subset (Apr 7, 2026-Sep 7,2026, n=162) from the First Hospital of Jilin University. | |
| External validation cohort | External validation cohort, consisting of consecutively enrolled eligible patients with ureteral calculi retrospectively collected from two independent external centers: Shanghai Changhai Hospital (Jan 1 - Sep 11, 2026, n=139) and The Second Hospital of Tianjin Medical University (Jan 1 - Jul 31, 2026, n=176). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Intraoperatively Confirmed Inflammatory Ureteral Polyps
The primary outcome is the presence or absence of inflammatory ureteral polyps confirmed by intraoperative pathology or direct visualization during ureteroscopy.
Measured: At the time of ureteroscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jan 2018
- Primary completion7 Sep 2026
- Study completion7 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,351 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbo Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559721
- Sponsor's protocol ID
- JLU-FH-2026-UROLITH-001
- Acronym
- UROLITH-POLYP
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Development of a Predictive Model for Stone-Associated Inflammatory Ureteral Polyps: A Retrospective Cohort Study With Prospective Validation
- ClinicalTrials.gov ID
- NCT07559721
- Acronym / sponsor ID
- UROLITH-POLYP / JLU-FH-2026-UROLITH-001
- Conditions
- Ureteral Calculi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,351 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 7 Sep 2026 (actual)
- Study completion
- 7 Sep 2026 (actual)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational studyincluding an internal retrospectivedevelopment cohort, an internalprospective temporal validation cohortand two external validation cohorts fromtwo independent external centers. Thestudy aims to identify independent riskfactors for inflammatory ureteral polypsin patients with ureteral calculi anddevelop a preoperative predictive model
Retrospective clinical and radiologicaldata were extracted from eligiblepatients treated from January 1, 2018to December 31, 2025 (n=874). Theprospective cohort consecutivelyenrolled participants from April 72026, to September 7, 2026 (n=162)Consecutive eligible patients from twoexternal centers were included forexternal validation (n=139 and n=176).The primary outcome is theintraoperative diagnosis of inflammatoryureteral polyps
Detailed description
This is a mixedretrospective-prospective observationalcohort study. The internal retrospectivedevelopment cohort (n=874) was fullyenrolled from January 1, 2018, toDecember 31, 2025, and was further splitinto a 70% training set and a 30%model-selection holdout set. Theinternal prospective temporal validationcohort consecutively enrolled eligibleparticipants from April 7, 2026, toSeptember 7, 2026 (n=162). Twoindependent external validation cohortsfrom two separate centers includedconsecutively enrolled patients withureteral calculi (n=139 and n=176)Preoperative clinical and radiologicaldata were collected to screenindependent risk factors and build apreoperative predictive model forinflammatory ureteral polyps. Theprimary endpoint was intraoperativediagnosis of inflammatory ureteralpolyps.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model development cohort, | – | –Model development cohort, including aninternal retrospective developmentsubset (Jan 1, 2018-Dec 31, 2025, n=874split into training and holdout set) andan internal prospective temporalvalidation subset (Apr 7, 2026-Sep 7,2026, n=162) from the First Hospital of Jilin University. |
| External validation cohort | – | –External validation cohort, consisting of consecutively enrolled eligible patients with ureteral calculi retrospectively collected from two independent external centers: Shanghai Changhai Hospital (Jan 1 - Sep 11, 2026, n=139) and The Second Hospital of Tianjin Medical University (Jan 1 - Jul 31, 2026, n=176). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients with ureteral calculi who underwent ureteroscopic treatment. The retrospective patients were enrolled at the First Hospital of Jilin University between 2018 and 2025. The prospective cohort consecutively enrolled new patients for validation between April 7 and September 7, 2026. Two additional independent external centers retrospectively collected consecutive eligible patients with ureteral calculi for external validation.
Key inclusion criteria (2 listed)
- Patients aged 18 years or older undergoing ureteroscopic surgery for ureteral calculi at the First Hospital of Jilin University.
- Complete clinical and imaging data available.
Key exclusion criteria (6 listed)
- Patients with bilateral ureteral calculi.
- Patients with preoperative nephrostomy or indwelling ureteral stent.
- Patients with a history of ureteral or bladder cancer.
- Patients with congenital ureteral anomalies or previous ureteral surgery.
- Patients with severe coagulation disorders or contraindications to ureteroscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Intraoperatively Confirmed Inflammatory Ureteral Polyps
Time frame: At the time of ureteroscopic surgery
The primary outcome is the presence or absence of inflammatory ureteral polyps confirmed by intraoperative pathology or direct visualization during ureteroscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Calculi, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Intraoperatively Confirmed Inflammatory Ureteral Polyps (time frame: At the time of ureteroscopic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.