A Prospective Observational study to describe the pattern and effectiveness of the utilization of different treatment options for Metastatic Renal Cell Carcinoma
Recruiting
- Conditions
- Patients with:-histologically confirmed metastatic renal cell cancer-treated by immunotherapy and/or TKIrenal cell carcinomaD09.7
- Registration Number
- LBCTR2020074518
- Lead Sponsor
- General Research Grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 185
Inclusion Criteria
Patients = 18 years old
-Histologically confirmed metastatic renal cell cancer
-Patients treated by immunotherapy and/or TKI
-Signed informed consent form obtained prior to study entry only for living patients
Exclusion Criteria
-History of another malignancy within the past 5 years except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix
-Pregnancy
-Current participation in another clinical trial
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: To describe the efficacy of immunotherapy and/or TKI alone for the treatment of metastatic renal cell carcinoma in terms of progression-free survival (PFS) and overall survival (OS);Timepoints: one and three years;Measure: Progression-free survival and duration of overall survival;Name: Assess the potency of the sequence therapy in terms of first, second, and third line therapy with the current real-world clinical practice;Timepoints: one and three years;Measure: Overall response rate, time to response and tumor assessment
- Secondary Outcome Measures
Name Time Method ame: To compare patients’ profile if the therapy is administered as first, second, or third line treatment options at one, three, six, twelve, and 36 months post treatment, and at 1st relapse;Timepoints: one, three, six, twelve, and 36 months post treatment, and at 1st relapse;Measure: Serious Adverse Events as pruritus, diarrhea and organ toxicity as liver, lungs, kidneys, thyroid and neurologic examination;Name: To describe the safety and toxicity profile of immunotherapy and/or TKI for fatigue, rash, nausea, pruritus and diarrhea and organ toxicity as liver, lungs, kidneys, thyroid and neurologic;Timepoints: one, three, six, twelve, and 36 months post treatment, and at 1st relapse;Measure: Lab data, ECG, Adverse events and serious adverse events