RECRUITINGOBSERVATIONAL
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib
Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib: a GENomic Signature for Describing Long-lasting Response
About This Trial
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 treatment that included TKIs, immune checkpoint inhibitors or mTOR inhibitors.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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.
Treatments Being Tested
DRUG
Cabozantinib
Patients must have been treated with cabozantinib after one or more previous therapies for mRCC, as per clinical practise.
Locations (1)
AUSL-IRCCS of Reggio Emilia
Reggio Emilia, Italy