Renal cell carcinoma Cancer Renal cell carcinoma
Conditions
Interventions
Patients will provide, on visit one (day one), a blood sample and urine sample for testing of plasma biomarkers, serum chemistry, haematology and metabolite analysis. These samples will again be taken
Sponsors
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed histologically or cytologically confirmed renal cell carcinoma with a clear cell component; patients who have a radiological diagnosis of probable renal cell carcinoma can be included whilst still awaiting biopsy or surgery and once confirmed to have clear cell renal cell carcinoma, they will be included in the study. If their histology confirms a non-clear cell renal cell carcinoma, they will be replaced. 2. Metastatic renal cell carcinoma with a clear cell component with previous nephrectomy but with no previous history of use of systemic therapy with the exception of immunotherapy, provera and bisphosphonates. Prior palliative radiotherapy is permitted. 3. Ability and willingness to provide written informed consent 4. Ability and willingness to co-operate with study procedures, including blood and urine sampling 5. Aged greater than or equal to 18 years, either sex
Exclusion criteria
Exclusion criteria: 1. Previous history of cancer other than RCC, autoimmune diseases or known active infection 2. Previous history of use of systemic therapy for treatment of renal cell carcinoma other than immunotherapy, provera and bisphosphonates. Prior palliative radiotherapy is not an exclusion criterion. 3. Patients who commence therapy in between study visits (sample collection); although if the first sample is already collected before starting treatment, then that sample will be processed and the second sample will not be collected 4. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, HBV and HCV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The principal objective is to establish the intra-individual and inter-individual variability in baseline reading of candidate angiogenic biomarkers in patients with clear cell RCC. Patient samples taken on day one and anytime from day 2 - 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study endpoint is to measure the baseline readings of angiogenic biomarkers in patients with clear cell RCC. Patient samples taken on day one and anytime from day 2 - 21. | — |
Countries
England, United Kingdom
Outcome results
None listed