Status:
RECRUITING
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib
Lead Sponsor:
Gruppo Oncologico Italiano di Ricerca Clinica
Collaborating Sponsors:
Yghea
Ipsen
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
CABOGEN is a Observational, retrospective, multicenter study that will enroll patients with metastatic clear cell renal carcinoma (mccRCC) treated with cabozantinib after one or more previous lines of...
Detailed Description
The aim of this study is to describe the genomic profiling of patients with metastatic renal cell carcinoma (mRCC) who are long-lasting responders to treatment with cabozantinib and patients who are n...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Patients with histological diagnosis of predominantly clear cell carcinoma
- Availability of the tumor tissue from the primary tumor and/or a metastatic site for the genomic profiling analysis not older than 5 years.
- Evaluable disease according to RECIST criteria v 1.1
- Treatment with cabozantinib after one or more previous therapies for mRCC
- Patient progressed from the start to cabozantinib therapy within 3 months or after 9 months
- Any prognosis group according to the IMDC risk score
- Signed informed consent must be obtained for living patients. Patients who died and patient untraceable will be analyzed based on the Authorization no. 9/2016 of the Italian Data Protector Supervisor.
Exclusion
- Non-availability of tumor tissue from the primary tumor or a metastatic site for biomarker analysis
- Patient progressed between 3 and 9 months from the beginning of treatment with cabozantinib.
- Non-availability of clinical information useful to evaluate the IMDC risk group at baseline.
Key Trial Info
Start Date :
May 28 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06548867
Start Date
May 28 2024
End Date
June 30 2025
Last Update
August 12 2024
Active Locations (1)
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1
AUSL-IRCCS of Reggio Emilia
Reggio Emilia, Italy, 42123