Biomarkers in patients with renal cell carcinoma

Not Applicable

Completed

• Conditions: Renal cell carcinoma; Cancer

• Registration Number: ISRCTN57274668
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-07
• Study Completion: 2012-01-31
• Last Update Posted: 20 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.