Plain English Summary
Background and study aims
Bone sarcoma is a cancer that begins in the bone and is very rare. It affects any bones in the body but mainly the legs. This is an observational project recruiting patients with a suspected or confirmed diagnosis of bone sarcoma. Blood samples are obtained and sent to Newcastle University for identification of circulating tumour cells. The aim of this study is to evaluate the effectiveness of a blood sample assay for the detection and enumeration of circulating tumour cells in patients diagnosed with a bone sarcoma at several points during their treatment process.
Who can participate?
Patients with suspected or confirmed bone sarcoma (any gender or rage range 4 to 80)
What does the study involve?
Participants are approached to donate blood samples (up to 20ml) which are immediately transported to Newcastle University for analysis at diagnosis, after chemotherapy, after surgery, completion of treatment and relapse (if appropriate).
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
This study is being run by Newcastle University and takes place in hospitals in the UK.
When is the study starting and how long is it expected to run for?
May 2014 to March 2022
Who is funding the study?
1. Bone Cancer Research Trust (UK)
2. Children with Cancer UK (UK)
Who is the main contact?
Mr Kenneth Rankin
kenneth.rankin@ncl.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mr Kenneth Rankin
ORCID ID
http://orcid.org/0000-0001-6302-0269
Contact details
Northern Institute for Cancer Research
Paul O’Gorman Building
Framlington Place
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 1912 223849
kenneth.rankin@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18501
Study information
Scientific title
Enumeration of circulating tumour cells in patients with bone sarcomas: an observational study
Acronym
Study hypothesis
The aim of this study is to evaluate the effectiveness of a blood sample assay for the detection and enumeration of circulating tumour cells in patients diagnosed with a bone sarcoma at several points during their treatment process.
Ethics approval
National Research Ethics Service Committee Yorkshire & The Humber - South Yorkshire, 24/12/2014, ref: 14YH/1314
Study design
Observational; Design type: Validation of outcome measures
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Specialty: Cancer, Primary sub-specialty: Sarcoma; UKCRC code/ Disease: Cancer/ Malignant neoplasms of bone and articular cartilage
Intervention
Participants are approached to donate blood samples (up to 20ml) which are immediately transported to Newcastle University for analysis at the following time points:
1. At diagnosis
2. Following neo-adjuvant chemotherapy
3. Following surgery
4. Following adjuvant chemotherapy
5. At routine follow-up on completion of treatment
6. At relapse (if appropriate)
Total duration of observation and follow-up are the same at up to five years.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Enumeration of circulating tumour cells is assessed using flow cytometry at diagnosis, during treatment stages and on completion of treatment to assess for changes in the circulating tumour cell counts.
Secondary outcome measures
1. Correlation of circulating tumour cell number measured by flow cytometry at diagnosis and subsequent treatment stages up to 5 years
2. Genomic analysis is undertaken using next generational sequencing at diagnosis and subsequent treatment stages up to 5 years
Overall trial start date
01/05/2014
Overall trial end date
31/03/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with a suspected bone sarcoma (any gender and age range 4 to 80 years old)
OR
2. Patients with a confirmed diagnosis of a bone sarcoma (any gender and age range 4 to 80 years old)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30
Participant exclusion criteria
1. Patients (or their parent/guardian for those under the age of 16) who are unable to give informed consent
2. Prisoners
3. Patients who are pregnant
Recruitment start date
07/04/2015
Recruitment end date
31/07/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Trial participating centre
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Trial participating centre
Royal Hospital for Sick Children
9 Sciennes Road
Edinburgh
EH9 1LF
United Kingdom
Trial participating centre
University College London Hospitals
Cancer Clinical Trials Unit
1st Floor East
250 Euston Road
London
NW1 2PG
United Kingdom
Trial participating centre
Birmingham Children’s Hospital
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
Funders
Funder type
Charity
Funder name
Bone Cancer Research Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Children with Cancer UK
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication date in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/03/2018
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN29619083_PIS_15Apr17_v1.3_adult.doc Uploaded 26/06/2017
- ISRCTN29619083_PIS_15Apr17_v1.3_parent.doc Uploaded 26/06/2017