An observational study in Urothelial Carcinoma, sponsored by Hoffmann-La Roche. Completed at 1 site in Argentina. Per ClinicalTrials.gov, last updated 2023-03-13.
Sponsored by Hoffmann-La Roche · Observational
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Among 12 studies in Carcinoma, Transitional Cell by Hoffmann-La Roche — none open to participants now, 1 under way, none of them phase 3. Carcinoma, Transitional Cell · Hoffmann-La Roche.
Among the 12 studies in Carcinoma, Transitional Cell by Hoffmann-La Roche, this one is one of 2 that started in 2018, is one of 4 observational ones, and was the 6th registered.
633 studies on the registry are indexed under Carcinoma, Transitional Cell; 180 are open to participants now.
Browse Carcinoma, Transitional Cell studies →None of the 12 studies in Carcinoma, Transitional Cell by Hoffmann-La Roche is open now. The open studies under Carcinoma, Transitional Cell, anywhere →
Of the 147 Carcinoma, Transitional Cell studies recruiting now, 121 (82%) set no upper age limit and 11 (7%) stop at 75 or younger; 4 take children under 18; 8 take healthy volunteers.
This study: 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.
12 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 4 · Phase 2 2 · Phase 3 2
First in 2015; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 13 is below the median of 300 across 107 observational studies indexed under Carcinoma, Transitional Cell.
Median enrollment 165 across the 7 interventional studies, 890 across the 4 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
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Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Carcinoma, Transitional Cell by Hoffmann-La Roche, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The main purpose is to study the safety and effectiveness of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment in common clinical practice settings in Argentina.
Patients with histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra) that have received the indication for treatment with atezolizumab as per local label (disease progression during or following platinum containing therapy) in the context of routine clinical practice.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Atezolizumab will be administered via IV at a 1200-mg dose over 60 minutes every 3 weeks (to be reduced to 30 minutes every 3 weeks if the first dose is tolerated).
Percentage of Participants with Adverse Events (AE)
Time frame: Up to approximately 2 years.
Percentage of participants with Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)
Time frame: Up to approximately 2 years.
Duration of Response (DOR)
Time frame: Up to approximately 2 years.
Progression Free Survival (PFS)
Time frame: Up to approximately 2 years.
Overall Survival (OS)
Time frame: Up to approximately 2 years.
Ran from Feb 2018 to primary completion in Mar 2019, 12 months.
Of 61 observational studies under Carcinoma, Transitional Cell, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 89. This study's 12 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 2023. You cannot join it, but the record below documents what was studied.
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