Actively Recruiting
Association Between the SPHERTEST In Vitro Test and Response to Checkpoint Inhibitor Treatments in Patients With Advanced or Metastatic Urothelial Carcinoma
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-01-28
32
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying advanced or metastatic urothelial carcinoma, a type of bladder cancer, to evaluate how well a new laboratory test called SPHERTEST predicts patient response to immunotherapy treatments known as checkpoint inhibitors. These treatments have become important after chemotherapy, but selecting the right therapy for each patient remains a challenge. The study aims to find a predictive signature using this in vitro model to better guide treatment choices. The SPHERTEST involves creating 3D clusters of cancer cells combined with immune cells from patients to test the effect of immunotherapy on tumor survival and immune response outside the body. This observational study collects blood from urothelial carcinoma patients before treatment to perform the test and then follows their clinical outcomes. The study also gathers detailed information about tumor characteristics, prior treatments, and immune markers. Participants will be monitored for one year to assess progression-free survival, alongside the SPHERTEST results. Various laboratory measures such as blood counts, tumor markers, and immune status will be recorded before and during treatment cycles. The research team will analyze how the SPHERTEST results relate to patient outcomes and other clinical factors, aiming to improve personalized treatment strategies for urothelial carcinoma.
CONDITIONS
Brief Title
Association Between the SPHERTEST in Vitro Test and Response to Checkpoint Inhibitor Treatments in Patients With Advanced or Metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with histologically proven urothelial carcinoma in a locally advanced or metastatic stage with indication for immunotherapy
- Patient has given free and informed consent and signed the consent form
- Patient is a member or beneficiary of a health insurance plan
You will not qualify if you...
- Participation in a category 1 or drug monotherapy interventional study or within an exclusion period from a previous study
- Unable to provide informed information
- Patient under safeguard of justice or state guardianship
- History of treatment with anti-PD1, anti-PDL1, or anti-CTLA4 within the past year
- Pregnant, parturient, or breastfeeding patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the SPHERTEST in vitro diagnostic test and various laboratory assessments to evaluate tumor characteristics and immune markers.
1 visit (in-person)
Duration - Up to 12 months
Participants are monitored for progression-free survival and other health outcomes following diagnostic testing.
Follow-up visits as per routine care
Trial Site Locations
Total: 5 locations
1
Institut du Cancer de Montpellier
Montpellier, France
Not Yet Recruiting
2
Institut Régional du Cancer de Montpellier
Montpellier, France
Not Yet Recruiting
3
Centre Antoine Lacassagne
Nice, France
Not Yet Recruiting
4
CHU de Nimes
Nîmes, France
Actively Recruiting
5
Iuct Oncopole
Toulouse, France
Actively Recruiting
Research Team
N
Nadine Houede
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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