An observational study in Urinary Bladder Cancer, sponsored by AstraZeneca. Completed at 17 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by AstraZeneca · Observational
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Among 20 studies in Urinary Bladder Neoplasms by AstraZeneca — 5 open to participants now, 11 under way, 4 of them phase 3. Urinary Bladder Neoplasms · AstraZeneca.
Among the 20 studies in Urinary Bladder Neoplasms by AstraZeneca, this one is one of 2 that started in 2020, is one of 6 observational ones, and was the 6th registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →5 of the 20 studies in Urinary Bladder Neoplasms by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Australia, Brazil and 13 more countries
Ages 18+
AstraZeneca · Sites in United States
Ages 18–130
AstraZeneca · Sites in Russia
Ages 18+
AstraZeneca · Sites in Australia, Brazil, Canada and 4 more countries
Ages 18+
AstraZeneca
Ages 18+
By country, each count listing its studies:
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 4 · Phase 4 1
First in 2003; this study’s year is marked. 2 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 248 is above the median of 200 across 412 observational studies indexed under Urinary Bladder Neoplasms.
Median enrollment 138 across the 14 interventional studies, 324 across the 6 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,502 studies on the registry; 273 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
2 of the studies in Urinary Bladder Neoplasms by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07038928AstraZenecaTReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation | 2026-12-31 |
| NCT04644068AstraZenecaStudy of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies | 2027-05-28 |
Add all 2 to your calendar (.ics) → With an account.
Among the 20 studies in Urinary Bladder Neoplasms by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.
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:
The exploratory objectives of this observational study are:
Patients with a new diagnosis of MIUBC
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Tumor tissue samples should be acquired within 60 days before the enrollment and available for testing.
Proportion of patients with different PD-L1 expression level
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
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
Distribution percent of different treatment approaches
Time frame: enrollment visit
2-year OS
follow up for OS up to 2 years from the baseline
Time frame: From enrollment to OS, up to 2 years
The prevalence of PD-L1 expression by subgroups
The prevalence of PD-L1 expression by subgroups according to age, gender, primary tumor site, metastatic disease, at baseline, and prior tobacco use, etc
Time frame: enrollment visit
OS by subgroups
OS by subgroups according to age, gender, primary tumor site, metastatic disease at baseline and the PD-L1 expression of high and low/negative as well as other biomarkers, etc. Simple correlation coefficients among biomarkers including PD-L1 with TMB, PD-L1 with CD8+ T cell, PD-L1+ IC with CD8+ T cell.
Time frame: from enrollment to OS, up to 2 years
Simple correlation coefficients among biomarkers
Simple correlation coefficients among biomarkers including PD-L1 with TMB, PD-L1 with CD8+ T cell, PD-L1 positive IC with CD8+ T cell.
Time frame: enrollment visit
Plan to share: No — Chinese Laws and Regulations don't allow
Ran from May 2020 to primary completion in Mar 2023, 34 months.
Of 203 observational studies under Urinary Bladder Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 33. This study's 34 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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