Biomarkers in patients with renal cell carcinoma
| ISRCTN | ISRCTN57274668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57274668 |
| Protocol serial number | BioM1 |
| Sponsors | Cambridge University Hospitals NHS Foundation Trust, University of Cambridge (UK) |
| Funders | Cambridge University Hospitals NHS Foundation Trust (UK) - Phase I Cancer Trials Team, Patterson Institute for Cancer Research (UK), St James University Hospital (UK) |
- Submission date
- 19/11/2010
- Registration date
- 07/02/2011
- Last edited
- 09/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-biomarkers-people-kidney-cancer
Contact information
Prof Duncan Jodrell
Scientific
Scientific
Oncology Centre, Box 193
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre prospective non-randomised observational study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Renal cancer biomarkers of angiogenesis in renal cell carcinoma (RCC): a multicentre, prospective, non-randomised, observational study |
| Study acronym | BioM1 |
| Study objectives | 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 renal cell carcinoma (RCC). |
| Ethics approval(s) | Cambridgeshire 1 REC pending as of 22/11/2010, ref: 10/H0304/096 |
| Health condition(s) or problem(s) studied | Renal cell carcinoma |
| Intervention | 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 on visit two (between days 2 and 21). Blood samples will be analysed at the Patterson Institute in Manchester, tests include (but are not limited to) VEGF, PIGF, sVEGFR-2, KGF, IL-8, FGF-ß, HGF, PDGF-BB, Ang1, Ang2, Tie2, SDF-1a, M65, M30. Plasma and urine samples will be analysed for various metabolites, including amino acids, sugars, oxoacids and osmolytes. The trial duration for the patient will be 28 days maximum. |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/01/2011 |
| Date of final enrolment | 31/01/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/09/2021: Cancer Research UK lay results summary link added to Results (plain English).
19/02/2018: No publications found, verifying study status with principal investigator.
19/11/2015: no publications found on PubMed.
