Urinary Bladder CancerPOLARISNCT03433924
An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.
An observational study of Urinary Bladder Cancer, run by AstraZeneca at 17 sites in China.
Trial summary
The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Cancer
- How many people
- 248 participants
- Where
- 17 sitesChina
- Study dates
- 18 May 2020to 27 Mar 2023
- 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 a new diagnosis of MIUBC
Who may be able to join
- Age ≥18 years at the time of screening.
- Be able and willing to sign the informed consent form (ICF).
- Patients with histologically or cytologically documented, muscle invasive urothelial carcinoma (ie, T2 toT4, any N, any M) of bladder (see National Comprehensive Cancer Network [NCCN] Bladder Cancer Guidelines), who had not been previously treated with any systemic chemotherapy, radiotherapy, investigational product, or biologic therapy for cancer treatment.
- For PD-L1 testing by IHC assay, all patients were able to provide a newly acquired tumor sample within 60 days before enrollment by cystectomy, transurethral resection or biopsy. Samples with limited tumor content and fine needle aspirate specimens were not acceptable. Specimens from metastatic bone lesions were typically unacceptable unless there was a significant soft tissue component. The tumor specimen submitted to establish PD-L1 status should be of sufficient quantity to allow for PD-L1 IHC analyses and was preferred in FFPE blocks.
Who cannot join
- Prior acquiring tumor tissue samples exposure to immune-mediated therapy (including Bacillus Calmette Guerin), including but not limited to, any anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, therapeutic anticancer vaccines.
- Any concurrent chemotherapy, investigational product, or biologic therapy for cancer treatment. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent was acceptable (eg, local surgery or radiotherapy).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Research Site
Beijing, 100034
Research Site
Beijing, 100730
Research Site
Changchun, 130021
Research Site
Changsha, 410013
Research Site
Chengdu, 610041
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510120
Research Site
Hangzhou, 310014
Research Site
Jinan, 250012
Research Site
Meizhou
Research Site
Nanjing, 2100008
Research Site
Shanghai, 200032
Research Site
Shanghai, 200072
Research Site
Shenyang, 110001
Research Site
Wuhan, CN-430030
Research Site
Xiamen, 361003
Research Site
Zhengzhou, 450052
About this study
Official title: An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation of Initial Treatment Pattern and Overall Survival in the Chinese Muscle Invasive Urothelial Bladder Carcinoma Patients.
The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.
Read the detailed description
The primary objective of this observational study is:
•To investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients. High PD-L1 expression is defined as ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
Note: PD-L1 High (>=25% tumor cell membrane positivity for PD-L1 or 1) IF IC area >1%: >=25% tumor associated immune cell positivity for PD-L1; 2) If IC area=1%: 100% tumor associated immune cell positivity for PD-L1). PD-L1 Low if criteria not met for PD-L1 High.
The second objectives of this observational study are:
- To investigate the PD-L1 expression profile in TC or IC in Chinese MIUBC patients.
- To assess the concordance of PD-L1 testing results generated from the hospital labs with those from the central lab.
- To observe the initial treatment pattern for MIUBC patients in usual clinical practice in China.
- To observe 2-year OS of the Chinese MIUBC patients.
The exploratory objectives of this observational study are:
- To explore the relationship between the demographic characteristics and expression of PD-L1 and other exploratory biomarkers including immune cell (IC) subset CD8+ T cells and tumor mutation burden (TMB).
- To explore the relationship between OS and the demographic characteristics as well as the expression of biomarkers.
- To explore the relationship between PD-L1 and TMB, PD-L1 and CD8 positive T cell respectively.
- Conditions
- Urinary Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of High PD-L1 expression in the MIUBC patients
Tumor tissue will be collected from all eligible patients who sign the ICF. Samples will be tested for PD-L1 expression status.
Measured: Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Secondary outcomes (4)
Proportion of patients with different PD-L1 expression level
Proportion of patients with different PD-L1 expression level
Measured: Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
PD-L1 testing concordance between central lab and hospital labs
PD-L1 testing concordance between central lab and hospital labs
Measured: Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Distribution percent of different treatment approaches
Distribution percent of different treatment approaches
Measured: enrollment visit
2-year OS
follow up for OS up to 2 years from the baseline
Measured: From enrollment to OS, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start18 May 2020
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Prospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liqun ZHOU, doctor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433924
- Sponsor's protocol ID
- D9012R00001
- Acronym
- POLARIS
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2018
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Chinese Laws and Regulations don't allow
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation of Initial Treatment Pattern and Overall Survival in the Chinese Muscle Invasive Urothelial Bladder Carcinoma Patients.
- ClinicalTrials.gov ID
- NCT03433924
- Acronym / sponsor ID
- POLARIS / D9012R00001
- Conditions
- Urinary Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 May 2020 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 15 Feb 2018 (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 Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.
Detailed description
The primary objective of this observational study is:
•To investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients. High PD-L1 expression is defined as ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
Note: PD-L1 High (>=25% tumor cell membrane positivity for PD-L1 or 1) IF IC area >1%: >=25% tumor associated immune cell positivity for PD-L1; 2) If IC area=1%: 100% tumor associated immune cell positivity for PD-L1). PD-L1 Low if criteria not met for PD-L1 High.
The second objectives of this observational study are:
- To investigate the PD-L1 expression profile in TC or IC in Chinese MIUBC patients.
- To assess the concordance of PD-L1 testing results generated from the hospital labs with those from the central lab.
- To observe the initial treatment pattern for MIUBC patients in usual clinical practice in China.
- To observe 2-year OS of the Chinese MIUBC patients.
The exploratory objectives of this observational study are:
- To explore the relationship between the demographic characteristics and expression of PD-L1 and other exploratory biomarkers including immune cell (IC) subset CD8+ T cells and tumor mutation burden (TMB).
- To explore the relationship between OS and the demographic characteristics as well as the expression of biomarkers.
- To explore the relationship between PD-L1 and TMB, PD-L1 and CD8 positive T cell respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a new diagnosis of MIUBC
Key inclusion criteria (4 listed)
- Age ≥18 years at the time of screening.
- Be able and willing to sign the informed consent form (ICF).
- Patients with histologically or cytologically documented, muscle invasive urothelial carcinoma (ie, T2 toT4, any N, any M) of bladder (see National Comprehensive Cancer Network [NCCN] Bladder Cancer Guidelines), who had not been previously treated with any systemic chemotherapy, radiotherapy, investigational product, or biologic therapy for cancer treatment.
- For PD-L1 testing by IHC assay, all patients were able to provide a newly acquired tumor sample within 60 days before enrollment by cystectomy, transurethral resection or biopsy. Samples with limited tumor content and fine needle aspirate specimens were not acceptable. Specimens from metastatic bone lesions were typically unacceptable unless there was a significant soft tissue component. The tumor specimen submitted to establish PD-L1 status should be of sufficient quantity to allow for PD-L1 IHC analyses and was preferred in FFPE blocks.
Key exclusion criteria (2 listed)
- Prior acquiring tumor tissue samples exposure to immune-mediated therapy (including Bacillus Calmette Guerin), including but not limited to, any anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, therapeutic anticancer vaccines.
- Any concurrent chemotherapy, investigational product, or biologic therapy for cancer treatment. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent was acceptable (eg, local surgery or radiotherapy).
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
the prevalence of High PD-L1 expression in the MIUBC patients
Time frame: Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Tumor tissue will be collected from all eligible patients who sign the ICF. Samples will be tested for PD-L1 expression status.
4 secondary outcomes
Proportion of patients with different PD-L1 expression level
Time frame: Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
PD-L1 testing concordance between central lab and hospital labs
Time frame: Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Distribution percent of different treatment approaches
Time frame: enrollment visit
2-year OS
Time frame: From enrollment to OS, up to 2 years
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 27 Mar 2024.
- CSR synopsis\_redacted and confirmd by GSDLink provided by the sponsor.
- Individual participant dataSharing planned: No. Chinese Laws and Regulations don't allow
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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.
Liqun ZHOU, doctor principal investigator
Peking University First Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Cancer, run by AstraZeneca at 17 sites 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 2 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 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
the prevalence of High PD-L1 expression in the MIUBC patients (time frame: Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.). 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 27 Mar 2024.