Urologic NeoplasmsYODONCT04052113
Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer
An observational study of Urologic Neoplasms, run by AstraZeneca at 1 site in Japan.
Trial summary
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urologic Neoplasms
- How many people
- 152 participants
- Where
- 1 siteJapan
- Study dates
- 25 Oct 2019to 23 Mar 2020
- 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: This study is a multi-center, non-interventional study, and Stage IV UC patients who have received at least 1 cycle of chemotherapy and have archived primary tumor sample collected after January 1st in 2017 will be of the interest. However, the patients who received immune oncology drug as 1st line treatment in stage IV will not be in this study.
Who may be able to join
- Age > 20, Japanese men and women.
- Patients who have started at least 1 cycle of chemotherapy.
- Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.
- Patients who are diagnosed as stage IV (T4b, any N or any T, N2-3 or M1) UC between January 1st in 2017 and December 31st in 2018.
- Patients who have FFPE primary tumor sample collected after January 1st in 2017. The sample should be collected before any therapies including 1st line treatment in stage IV and therapies in stage III and other stages. It is possible to send sliced undyed section of primary tumor including 1 HE-stained section of same sample in case that patients cannot send FFPE primary tumor block.
Who cannot join
- -Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected to assay PD-L1 expression and next generation sequencer (NGS) assay for tumor mutation burden (TMB).
Read the detailed description
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected from each site and conduct programmed cell death 1 ligand 1 (PD-L1) assay and next generation sequencer (NGS) assay for tumor mutation burden (TMB). Based on these data, prevalence of PD-L1, TMB and overall survival (OS), progression free survival (PFS) from start of 1st line treatment in stage IV will be assessed.
In this study, 150 patients will be enrolled from approximately 30 sites in Japan. The patients should have received at least 1 cycle of chemotherapy and never receive immune oncology drug as 1st line treatment in stage IV. The patients will be enrolled continuously from the 1st patient who is enrolled in this study until target number of patients in each site.
- Conditions
- Urologic Neoplasms
- Keywords
- Real world, PD-L1, TMB, Stage IV, urothelial cancer, Japanese
- Medical subject headings
- Urologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of PD-L1 in stage IV UC patients in real world setting.
Summarize number and calculate ratio of PD-L1 high or low/negative patients, respectively.
Measured: Baseline
Secondary outcomes (3)
Prevalence of TMB in stage IV UC patients in real world setting.
Calculate median and average of TMB levels. Summarize number and calculate ratio of TMB high or low/negative patients, respectively.
Measured: Baseline
OS from start of 1st line treatment in stage IV
Median OS and OS rate at 12 months, 18 months and 24 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
Measured: 2 years
PFS from start of 1st line treatment in stage IV
Median PFS and PFS rate at 6months, 12months and 18 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start25 Oct 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic NeoplasmsStudies 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
- Cross-sectional
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052113
- Sponsor's protocol ID
- D419BR00014
- Acronym
- YODO
- Status last verified
- Feb 2021
- First submitted
- 22 Jul 2019
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer
- ClinicalTrials.gov ID
- NCT04052113
- Acronym / sponsor ID
- YODO / D419BR00014
- Conditions
- Urologic Neoplasms
- Keywords
- Real world, PD-L1, TMB, Stage IV, urothelial cancer, Japanese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 9 Aug 2019 (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.
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected to assay PD-L1 expression and next generation sequencer (NGS) assay for tumor mutation burden (TMB).
Detailed description
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected from each site and conduct programmed cell death 1 ligand 1 (PD-L1) assay and next generation sequencer (NGS) assay for tumor mutation burden (TMB). Based on these data, prevalence of PD-L1, TMB and overall survival (OS), progression free survival (PFS) from start of 1st line treatment in stage IV will be assessed.
In this study, 150 patients will be enrolled from approximately 30 sites in Japan. The patients should have received at least 1 cycle of chemotherapy and never receive immune oncology drug as 1st line treatment in stage IV. The patients will be enrolled continuously from the 1st patient who is enrolled in this study until target number of patients in each site.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is a multi-center, non-interventional study, and Stage IV UC patients who have received at least 1 cycle of chemotherapy and have archived primary tumor sample collected after January 1st in 2017 will be of the interest. However, the patients who received immune oncology drug as 1st line treatment in stage IV will not be in this study.
Key inclusion criteria (5 listed)
- Age > 20, Japanese men and women.
- Patients who have started at least 1 cycle of chemotherapy.
- Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.
- Patients who are diagnosed as stage IV (T4b, any N or any T, N2-3 or M1) UC between January 1st in 2017 and December 31st in 2018.
- Patients who have FFPE primary tumor sample collected after January 1st in 2017. The sample should be collected before any therapies including 1st line treatment in stage IV and therapies in stage III and other stages. It is possible to send sliced undyed section of primary tumor including 1 HE-stained section of same sample in case that patients cannot send FFPE primary tumor block.
Key exclusion criteria (1 listed)
- -Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.
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
Prevalence of PD-L1 in stage IV UC patients in real world setting.
Time frame: Baseline
Summarize number and calculate ratio of PD-L1 high or low/negative patients, respectively.
3 secondary outcomes
Prevalence of TMB in stage IV UC patients in real world setting.
Time frame: Baseline
OS from start of 1st line treatment in stage IV
Time frame: 2 years
PFS from start of 1st line treatment in stage IV
Time frame: 18 months
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 1 Mar 2021.
- Redacted SynopsisLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Urologic Neoplasms, run by AstraZeneca at 1 site in Japan.
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 5 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 1 Mar 2021. 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 Japan. 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?
Prevalence of PD-L1 in stage IV UC patients in real world setting. (time frame: Baseline). 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 1 Mar 2021.