Urothelial CarcinomaNCT06169904
B7-Family Score in Urothelial Carcinoma
An observational study of Urothelial Carcinoma, run by Shanghai Zhongshan Hospital.
Trial summary
Immunotherapy has been found to confer substantial survival benefits to the patients with higher mutation burdens, which become the first biomarker approved by FDA in urothelial carcinoma (UC). Nevertheless, among the patients with high mutation burdens, some still remained refractory to immunotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Cisplatin injection
- Type of treatment
- Injection or infusion
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2012to 22 Nov 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Among the 215 patients originally diagnosed with bladder cancer who underwent radical cystectomy at Zhongshan Hospital of Fudan University from 2002 to 2014, eighty-seven patients were excluded: 60 patients without muscle-invasive bladder cancer (MIBC), 13 patients with non-urothelial carcinoma, and 36 specimens with dots lost on the tissue microarray (TMA) during the immunohistochemistry (IHC) assay. Therefore, 106 patients are enrolled in the ZSHS cohort, 51 of whom received adjuvant cisplatin-based chemotherapy which lasted at least one therapeutic cycle. The overall survival (OS) and the recurrence-free survival (RFS) were defined as the period from the date of RC to the date of death or first recurrence, or to the latest follow-up.
Who may be able to join
- Patients with muscle-invasive bladder cancer receiving radical cystectomy have been included in this study.
Who cannot join
- Patients with non-muscle invasive bladder cancer were not eligible in this study.
About this study
Official title: B7-Family Score Predicts Clinical Outcome From Chemotherapy and Checkpoint Blockade for Patients With Urothelial Carcinoma
Immunotherapy has been found to confer substantial survival benefits to the patients with higher mutation burdens, which become the first biomarker approved by FDA in urothelial carcinoma (UC). Nevertheless, among the patients with high mutation burdens, some still remained refractory to immunotherapy. The B7 family molecules have long been perceived as vital determinant of immune response and may define dominant molecular subsets associated with immunotherapeutic response. Simultaneously, our previous study (Eur J Cancer. 2022,171:133-142) unveiled the potential of B7-H4 as a candidate biomarker to refine the predictive capability of tumor mutation burden (TMB) in immunotherapeutic efficacy based on its significant correlation with TMB in MIBC. We hypothesized that the integration of B7 family molecules with TMB could better identify patients with better response to checkpoint blockade.
In this retrospective study, a total of 1,084 UC patients from 5 independent cohorts were enrolled. We established the B7 Family Score (BFS) by the expression patterns of three B7 family members: PD-L1 (CD274), B7-H3 (CD276) and B7-H4 (VTCN1) based on protein and transcriptomic level respectively. We further investigated the correlation of BFS with genomic features and therapeutic response in UC. In addition, we integrated the BFS with tumor mutation burden (TMB) to better stratify the clinical benefit from PD-L1 blockade and platinum-based chemotherapy.
Read the detailed description
On the basis of established findings in the prognostic and functional properties of the three B7 family members, i.e., PD-L1, B7-H3, and B7-H4, we employed the IMVigor210 cohort as the discovery cohort to establish the concept of B7 Family Score (BFS). To maximize the prognostic value of the system, we introduced the R package survMisc (0.5.5) in the IMvigor210 cohort to determine the best cut-off value of mRNA expression level of the B7 family members (i.e. CD274, CD276, and VTCN1) by calculating the minimum log-rank P value accordingly.
- Conditions
- Urothelial Carcinoma
- Being tested
- Cisplatin injection
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin injectionDrug
Also called Atezolizumab injection
We observed the UC patients from Zhongshan Hospital receiving or not receiving adjuvant cisplatin-based chemotherapy after radical cystectomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
The time when patients died is the primary outcome measure.
Measured: 1/1/2002-1/1/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start25 Jan 2012
- Primary completion25 Aug 2020
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169904
- Sponsor's protocol ID
- FUDAN-BLCA-01
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B7-Family Score Predicts Clinical Outcome From Chemotherapy and Checkpoint Blockade for Patients With Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06169904
- Acronym / sponsor ID
- FUDAN-BLCA-01
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Fudan University, Shanghai Jiao Tong University School of Medicine
- Study start
- 25 Jan 2012 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 14 Dec 2023 (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.
Immunotherapy has been found to confer substantial survival benefits to the patients with higher mutation burdens, which become the first biomarker approved by FDA in urothelial carcinoma (UC). Nevertheless, among the patients with high mutation burdens, some still remained refractory to immunotherapy. The B7 family molecules have long been perceived as vital determinant of immune response and may define dominant molecular subsets associated with immunotherapeutic response. Simultaneously, our previous study (Eur J Cancer. 2022,171:133-142) unveiled the potential of B7-H4 as a candidate biomarker to refine the predictive capability of tumor mutation burden (TMB) in immunotherapeutic efficacy based on its significant correlation with TMB in MIBC. We hypothesized that the integration of B7 family molecules with TMB could better identify patients with better response to checkpoint blockade.
In this retrospective study, a total of 1,084 UC patients from 5 independent cohorts were enrolled. We established the B7 Family Score (BFS) by the expression patterns of three B7 family members: PD-L1 (CD274), B7-H3 (CD276) and B7-H4 (VTCN1) based on protein and transcriptomic level respectively. We further investigated the correlation of BFS with genomic features and therapeutic response in UC. In addition, we integrated the BFS with tumor mutation burden (TMB) to better stratify the clinical benefit from PD-L1 blockade and platinum-based chemotherapy.
Detailed description
On the basis of established findings in the prognostic and functional properties of the three B7 family members, i.e., PD-L1, B7-H3, and B7-H4, we employed the IMVigor210 cohort as the discovery cohort to establish the concept of B7 Family Score (BFS). To maximize the prognostic value of the system, we introduced the R package survMisc (0.5.5) in the IMvigor210 cohort to determine the best cut-off value of mRNA expression level of the B7 family members (i.e. CD274, CD276, and VTCN1) by calculating the minimum log-rank P value accordingly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Among the 215 patients originally diagnosed with bladder cancer who underwent radical cystectomy at Zhongshan Hospital of Fudan University from 2002 to 2014, eighty-seven patients were excluded: 60 patients without muscle-invasive bladder cancer (MIBC), 13 patients with non-urothelial carcinoma, and 36 specimens with dots lost on the tissue microarray (TMA) during the immunohistochemistry (IHC) assay. Therefore, 106 patients are enrolled in the ZSHS cohort, 51 of whom received adjuvant cisplatin-based chemotherapy which lasted at least one therapeutic cycle. The overall survival (OS) and the recurrence-free survival (RFS) were defined as the period from the date of RC to the date of death or first recurrence, or to the latest follow-up.
Key inclusion criteria (1 listed)
- Patients with muscle-invasive bladder cancer receiving radical cystectomy have been included in this study.
Key exclusion criteria (1 listed)
- Patients with non-muscle invasive bladder cancer were not eligible 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin injectionAlso: Atezolizumab injectionWe observed the UC patients from Zhongshan Hospital receiving or not receiving adjuvant cisplatin-based chemotherapy after radical cystectomy. | Drug | – |
Primary outcome
Death
Time frame: 1/1/2002-1/1/2022
The time when patients died is the primary outcome measure.
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 14 Dec 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Shanghai Zhongshan Hospital.
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 1 inclusion and 1 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Death (time frame: 1/1/2002-1/1/2022). 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 14 Dec 2023.