Can cancer cells be found and counted in blood samples from patients with bone sarcoma?
| ISRCTN | ISRCTN29619083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29619083 |
| Secondary identifying numbers | 18501 |
- Submission date
- 05/06/2017
- Registration date
- 26/06/2017
- Last edited
- 15/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Public
Northern Institute for Cancer Research
Paul O’Gorman Building
Framlington Place
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0001-6302-0269 |
|---|---|
| Phone | +44 1912 223849 |
| kenneth.rankin@ncl.ac.uk |
Study information
| Study design | Observational; Design type: Validation of outcome measures |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN29619083_PIS_15Apr17_v1.3_adult.doc |
| Scientific title | Enumeration of circulating tumour cells in patients with bone sarcomas: an observational study |
| Study objectives | 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(s) | National Research Ethics Service Committee Yorkshire & The Humber - South Yorkshire, 24/12/2014, ref: 14YH/1314 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2014 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 30; UK Sample Size: 30 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 07/04/2015 |
| Date of final enrolment | 31/07/2017 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Newcastle upon Tyne
NE7 7DN
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Edinburgh
EH9 1LF
United Kingdom
1st Floor East
250 Euston Road
London
NW1 2PG
United Kingdom
Birmingham
B4 6NH
United Kingdom
Sponsor information
Hospital/treatment centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle-Upon-Tyne
NE7 7DN
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Charity
No information available
No information available
Results and Publications
| Intention to publish date | 31/03/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication date in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.3 | 15/04/2017 | 26/06/2017 | No | Yes |
| Participant information sheet | version v1.3 | 15/04/2017 | 26/06/2017 | No | Yes |
Additional files
- ISRCTN29619083_PIS_15Apr17_v1.3_adult.doc
- Uploaded 26/06/2017
- ISRCTN29619083_PIS_15Apr17_v1.3_parent.doc
- Uploaded 26/06/2017
Editorial Notes
15/03/2022: Typo in public title corrected.
15/01/2018: The Plain English summary has been added.
24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.
13/10/2017: Internal review.
