Biomarkers in patients with renal cell carcinoma

ISRCTN	ISRCTN57274668
DOI	https://doi.org/10.1186/ISRCTN57274668
Secondary identifying numbers	BioM1

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

Oncology Centre, Box 193
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Study information

Study design	Multicentre prospective non-randomised observational study
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	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	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.
Overall study start date	04/01/2011
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust
Hospital/treatment centre

Trust R&D Dept, Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Website	http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
"ROR"	https://ror.org/04v54gj93

University of Cambridge (UK)
University/education

Research Office
School of Clinical Medicine
Addenbrooke's Hospital, Box 111
Hills Road
Cambridge
CB2 0SP
England
United Kingdom

Phone	+44 (0)1223 333543
Email	croenquiries@admin.cam.ac.uk
Website	http://www.cam.ac.uk/

Funders

Funder type

Government

Cambridge University Hospitals NHS Foundation Trust (UK) - Phase I Cancer Trials Team

No information available

Patterson Institute for Cancer Research (UK)

No information available

St James University Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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.