Condition category
Cancer
Date applied
19/11/2010
Date assigned
07/02/2011
Last edited
19/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Duncan Jodrell

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BioM1

Study information

Scientific title

Renal cancer biomarkers of angiogenesis in renal cell carcinoma (RCC): a multicentre, prospective, non-randomised, observational study

Acronym

BioM1

Study hypothesis

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

Cambridgeshire 1 REC pending as of 22/11/2010 (ref: 10/H0304/096)

Study design

Multicentre prospective non-randomised observational study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

04/01/2011

Overall trial end date

31/01/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

04/01/2011

Recruitment end date

31/01/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Organisation

University of Cambridge (UK)

Sponsor details

Research Office
School of Clinical Medicine
Addenbrooke's Hospital
Box 111
Hills Road
Cambridge
CB2 0SP
United Kingdom
+44 (0)1223 333543
croenquiries@admin.cam.ac.uk

Sponsor type

University/education

Website

http://www.cam.ac.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Patterson Institute for Cancer Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

St James University Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/11/2015: no publications found on PubMed.