Bladder CancerNCT06381895
The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer
An observational study of Bladder Cancer and Radiomics, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Radiomics, Immunotherapy
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 20 Feb 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: Patients with histologically confirmed primary bladder cancers
Who may be able to join
- At least 18 years of age;
- Performing TURB-t or RC during 2010-2022;
- The primary lesion was located in the bladder, and the pathological diagnosis was urothelial carcinoma;
- Complete clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records;
Who cannot join
- Patients with distant metastasis;
- Combined with other malignant tumors or malignant tumor treatment history
- Malignant tumors of upper urinary tract;
- Clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records were missing;
- Other situations in which the researcher considers it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated.
- Conditions
- Bladder Cancer, Radiomics, Immunotherapy
- Medical subject headings
- Urinary Bladder Neoplasms
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 |
|---|---|---|
| 1 | Sun Yat-sen Memorial Hospital cohort | |
| 2 | Third Affiliated Hospital of Sun Yat-sen University cohort | |
| 3 | Sun Yat-sen University Cancer Center cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour-infiltrating lymphocytes (TIL)
TILs were evaluated using paraffin-embedded tumour tissue samples stained with H\&E according to established protocols.
Measured: 1 year
Secondary outcomes (2)
overall survival
We obtain this data through telephone follow-up and evaluate it according to the date of surgery
Measured: 1 year
cancer-specific survival
We obtain this data through telephone follow-up and evaluate it according to the date of surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start30 May 2023
- Primary completion1 Feb 2024
- Study completion20 Feb 2024
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 Bladder CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liushan Ou, Study chair, Medical Ethics Committee, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381895
- Sponsor's protocol ID
- SYSKY-2023-467-01
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen K, Li X, Liu L, Wang B, Liang W, Chen J, Gao M, Huang X, Liu B, Sun X, Yang T, Zhao X, He W, Luo Y, Huang J, Lin T, Zhong W. Correlation of noninvasive imaging of tumour-infiltrating lymphocytes with survival and BCG immunotherapy response in patients with bladder cancer: a multicentre cohort study. Int J Surg. 2025 Jan 1;111(1):920-931. doi: 10.1097/JS9.0000000000001999.
PubMed 40053821
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT06381895
- Acronym / sponsor ID
- SYSKY-2023-467-01
- Conditions
- Bladder Cancer, Radiomics, Immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 24 Apr 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.
The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Sun Yat-sen Memorial Hospital cohort |
| 2 | – | –Third Affiliated Hospital of Sun Yat-sen University cohort |
| 3 | – | –Sun Yat-sen University Cancer Center cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed primary bladder cancers
Key inclusion criteria (4 listed)
- At least 18 years of age;
- Performing TURB-t or RC during 2010-2022;
- The primary lesion was located in the bladder, and the pathological diagnosis was urothelial carcinoma;
- Complete clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records;
Key exclusion criteria (5 listed)
- Patients with distant metastasis;
- Combined with other malignant tumors or malignant tumor treatment history
- Malignant tumors of upper urinary tract;
- Clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records were missing;
- Other situations in which the researcher considers it inappropriate to participate in this study.
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
Tumour-infiltrating lymphocytes (TIL)
Time frame: 1 year
TILs were evaluated using paraffin-embedded tumour tissue samples stained with H\&E according to established protocols.
2 secondary outcomes
overall survival
Time frame: 1 year
cancer-specific survival
Time frame: 1 year
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 24 Apr 2024.
- Derived from this study: PubMed 40053821Chen K, Li X, Liu L, Wang B, Liang W, Chen J, Gao M, Huang X, Liu B, Sun X, Yang T, Zhao X, He W, Luo Y, Huang J, Lin T, Zhong W. Correlation of noninvasive imaging of tumour-infiltrating lymphocytes with survival and BCG immunotherapy response in patients with bladder cancer: a multicentre cohort study. Int J Surg. 2025 Jan 1;111(1):920-931. doi: 10.1097/JS9.0000000000001999.
- 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.
Liushan Ou study chair
Medical Ethics Committee, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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 Bladder Cancer and Radiomics, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 4 inclusion and 5 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 24 Apr 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?
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?
Tumour-infiltrating lymphocytes (TIL) (time frame: 1 year). 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 NCT06381895, 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 24 Apr 2024.