Non-Muscle-Invasive Bladder CancerNCT06245759
The Prognostic Impact of Tumor Location in Non-Muscle-Invasive Bladder Cancer Patients
An observational study of Non-Muscle-Invasive Bladder Cancer and Bladder Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Based on large sample size studies at home and abroad, the prognosis of patients with non-muscular invasive bladder cancer in different sites undergoing transurethral bladder tumor resection was determined, providing important guidance for subsequent clinical treatment and surgical instrument development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle-Invasive Bladder Cancer, Bladder Cancer
- What is being tested?
- This was a retrospective study and no patient intervention was performed
- How many people
- 120,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2023to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study utilized the Chinese NMIBC cohort as well as the SEER 17 registries cohort for its investigation. The Chinese NMIBC cohort contains data of patients between January 1996 and December 2019, at 14 institutions. SEER*Stat software (version 8.4.1.1) was used for collecting 17 registries cohort data on patients diagnosed with NMIBC between 2000 and 2020.
Who may be able to join
- Initially diagnosed with non-muscular invasive bladder cancer (NMIBC) who underwent TURBT or partial cystectomy.
- The follow-up data of the patients were complete.
- The tumor location information were complete.
Who cannot join
- Patients with unknown survival time or missing tumor location information were excluded.
- Exclude patients with missing pathological results.
- Exclude patients who have had TURBT before.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ke Chen
Wuhan, Hubei, 430022
Lilong Liu, +8618186431204, ddluis1204@163.com
About this study
Official title: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Based on large sample size studies at home and abroad, the prognosis of patients with non-muscular invasive bladder cancer in different sites undergoing transurethral bladder tumor resection was determined, providing important guidance for subsequent clinical treatment and surgical instrument development.
Read the detailed description
Background Most bladder cancers are non-muscle invasive bladder cancer (NMIBC), and transurethral resection of bladder tumors (TURBT) is the standard treatment. However, postoperative recurrence poses a challenge, and the influence of bladder tumor location on prognosis is unclear. This study aims to investigate how tumor location affects NMIBC patients' prognosis undergoing TURBT, and seeks optimal surgical approaches.
Methods Conducted a multicenter study, including Chinese NMIBC data from 15 hospitals (1996-2019) and SEER 17 registries (2000-2020). Analyzed patients initially diagnosed with NMIBC undergoing TURBT or partial cystectomy, excluding cases with lost follow-up or missing data. Studied overall survival (OS), disease-specific survival (DSS), and recurrence-free survival (RFS). Employed Kaplan-Meier, Cox regression, and propensity score matching to explore the association between tumor location and prognosis. Stratified populations were analyzed to minimize bias.
Findings This study, involving 118,477 NMIBC patients, highlighted tumor location as a crucial factor impacting post-TURBT prognosis. Anterior wall and dome tumors independently predicted adverse outcomes in both cohorts. For anterior wall tumors, Chinese cohort showed OS HR 4.35, p < 0.0001; RFS HR 2.21, p < 0.0001; SEER OS HR 1.10, p = 0.0001; DSS HR 1.13, p = 0.0183. Dome tumors displayed similar trends (Chinese NMIBC cohort OS HR 7.91, p < 0.0001; RFS HR 2.12, p < 0.0001; SEER OS HR 1.05, p = 0.0087; DSS HR 1.14, p = 0.0006). Partial cystectomy significantly improved dome tumor survival compared to standard TURBT (p < 0.01).
Interpretation This study reveal that NMIBC tumor location significantly influences TURBT treatment outcomes. Specifically, tumors in the anterior wall and bladder dome have worse post-TURBT prognosis. Compared to TURBT, partial cystectomy improves prognosis for bladder dome tumors. This study guides personalized treatment and prognosis management for NMIBC patients.
- Conditions
- Non-Muscle-Invasive Bladder Cancer, Bladder Cancer
- Being tested
- This was a retrospective study and no patient intervention was performed
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This was a retrospective study and no patient intervention was performedOther
This was a retrospective study and no patient intervention was performed
| Study group | Role | What they receive |
|---|---|---|
| the U.S. National Cancer Center SEER database | The Chinese NMIBC cohort includes patients from January 1996 to December 2019 at 15 institutions. Receives: Other: This was a retrospective study and no patient intervention was performed | |
| the Chinese Bladder Cancer Alliance CBCC database | SEER*Stat software (version 8.4.1.1) collected 17 registries cohort data on NMIBC patients diagnosed between 2000 and 2020. Receives: Other: This was a retrospective study and no patient intervention was performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time
OS, defined as the time from the first diagnosis to death from any cause or the last follow-up for surviving patients
Measured: up to 20 years
Recurrence free survival time
Recurrence-free survival (RFS) is the time from the time a patient achieved complete response after antineoplastic therapy to the time of recurrence or the end of follow-up. The longer the relapse-free survival time, the better the efficacy of anti-tumor therapy.
Measured: up to 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start31 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Muscle-Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Retrospective
- Enrolment
- 120,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilong Liu, Huazhong University of Science and Technology
- Investigators
- Ke Chen, MD/PhD, Study chair, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245759
- Sponsor's protocol ID
- TJIRB20230888
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu L, Li K, Wang SG, Wang J, Yao Z, Xie Y, Ji Z, Chen Z, Hu H, Chen H, Hu J, Hou Y, Liu Z, Li Y, Ding Y, Kuang Y, Xun Y, Hu J, Zhang J, Li H, Chong T, Bi J, Wang Z, Wang Y, Zhang P, Wei Q, Chen Z, Li L, Huang J, Liu Z, Chen K; Chinese Bladder Cancer Consortium. The prognostic impact of tumor location in nonmuscle-invasive bladder cancer patients undergoing transurethral resection: insights from a cohort study utilizing Chinese multicenter and SEER registries. Int J Surg. 2024 Sep 1;110(9):5641-5651. doi: 10.1097/JS9.0000000000001675.
PubMed 38788195
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
- ClinicalTrials.gov ID
- NCT06245759
- Acronym / sponsor ID
- TJIRB20230888
- Conditions
- Non-Muscle-Invasive Bladder Cancer, Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Feb 2024 (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.
Based on large sample size studies at home and abroad, the prognosis of patients with non-muscular invasive bladder cancer in different sites undergoing transurethral bladder tumor resection was determined, providing important guidance for subsequent clinical treatment and surgical instrument development.
Detailed description
Background Most bladder cancers are non-muscle invasive bladder cancer (NMIBC), and transurethral resection of bladder tumors (TURBT) is the standard treatment. However, postoperative recurrence poses a challenge, and the influence of bladder tumor location on prognosis is unclear. This study aims to investigate how tumor location affects NMIBC patients' prognosis undergoing TURBT, and seeks optimal surgical approaches.
Methods Conducted a multicenter study, including Chinese NMIBC data from 15 hospitals (1996-2019) and SEER 17 registries (2000-2020). Analyzed patients initially diagnosed with NMIBC undergoing TURBT or partial cystectomy, excluding cases with lost follow-up or missing data. Studied overall survival (OS), disease-specific survival (DSS), and recurrence-free survival (RFS). Employed Kaplan-Meier, Cox regression, and propensity score matching to explore the association between tumor location and prognosis. Stratified populations were analyzed to minimize bias.
Findings This study, involving 118,477 NMIBC patients, highlighted tumor location as a crucial factor impacting post-TURBT prognosis. Anterior wall and dome tumors independently predicted adverse outcomes in both cohorts. For anterior wall tumors, Chinese cohort showed OS HR 4.35, p < 0.0001; RFS HR 2.21, p < 0.0001; SEER OS HR 1.10, p = 0.0001; DSS HR 1.13, p = 0.0183. Dome tumors displayed similar trends (Chinese NMIBC cohort OS HR 7.91, p < 0.0001; RFS HR 2.12, p < 0.0001; SEER OS HR 1.05, p = 0.0087; DSS HR 1.14, p = 0.0006). Partial cystectomy significantly improved dome tumor survival compared to standard TURBT (p < 0.01).
Interpretation This study reveal that NMIBC tumor location significantly influences TURBT treatment outcomes. Specifically, tumors in the anterior wall and bladder dome have worse post-TURBT prognosis. Compared to TURBT, partial cystectomy improves prognosis for bladder dome tumors. This study guides personalized treatment and prognosis management for NMIBC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the U.S. National Cancer Center SEER database | – | Other: This was a retrospective study and no patient intervention was performedThe Chinese NMIBC cohort includes patients from January 1996 to December 2019 at 15 institutions. |
| the Chinese Bladder Cancer Alliance CBCC database | – | Other: This was a retrospective study and no patient intervention was performedSEER*Stat software (version 8.4.1.1) collected 17 registries cohort data on NMIBC patients diagnosed between 2000 and 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study utilized the Chinese NMIBC cohort as well as the SEER 17 registries cohort for its investigation. The Chinese NMIBC cohort contains data of patients between January 1996 and December 2019, at 14 institutions. SEER*Stat software (version 8.4.1.1) was used for collecting 17 registries cohort data on patients diagnosed with NMIBC between 2000 and 2020.
Key inclusion criteria (3 listed)
- Initially diagnosed with non-muscular invasive bladder cancer (NMIBC) who underwent TURBT or partial cystectomy.
- The follow-up data of the patients were complete.
- The tumor location information were complete.
Key exclusion criteria (3 listed)
- Patients with unknown survival time or missing tumor location information were excluded.
- Exclude patients with missing pathological results.
- Exclude patients who have had TURBT before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This was a retrospective study and no patient intervention was performedThis was a retrospective study and no patient intervention was performed | Other | the Chinese Bladder Cancer Alliance CBCC database, the U.S. National Cancer Center SEER database |
Primary outcome
Overall survival time
Time frame: up to 20 years
OS, defined as the time from the first diagnosis to death from any cause or the last follow-up for surviving patients
Recurrence free survival time
Time frame: up to 16 years
Recurrence-free survival (RFS) is the time from the time a patient achieved complete response after antineoplastic therapy to the time of recurrence or the end of follow-up. The longer the relapse-free survival time, the better the efficacy of anti-tumor therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 38788195Liu L, Li K, Wang SG, Wang J, Yao Z, Xie Y, Ji Z, Chen Z, Hu H, Chen H, Hu J, Hou Y, Liu Z, Li Y, Ding Y, Kuang Y, Xun Y, Hu J, Zhang J, Li H, Chong T, Bi J, Wang Z, Wang Y, Zhang P, Wei Q, Chen Z, Li L, Huang J, Liu Z, Chen K; Chinese Bladder Cancer Consortium. The prognostic impact of tumor location in nonmuscle-invasive bladder cancer patients undergoing transurethral resection: insights from a cohort study utilizing Chinese multicenter and SEER registries. Int J Surg. 2024 Sep 1;110(9):5641-5651. doi: 10.1097/JS9.0000000000001675.
- Individual participant dataSharing planned: No
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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.
Ke Chen, MD/PhD study chair
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
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 Non-Muscle-Invasive Bladder Cancer and Bladder Cancer, run by Huazhong University of Science and Technology 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pu Zhou, MD (+86 27 83662379, tongjihlunli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival time (time frame: up to 20 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06245759, which also lists 1 linked publication.
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 7 Feb 2024.