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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Mr Kenneth Rankin
Public

Northern Institute for Cancer Research
Paul O’Gorman Building
Framlington Place
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom

ORCiD logoORCID ID 0000-0001-6302-0269
Phone +44 1912 223849
Email kenneth.rankin@ncl.ac.uk

Study information

Study designObservational; Design type: Validation of outcome measures
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN29619083_PIS_15Apr17_v1.3_adult.doc
Scientific titleEnumeration of circulating tumour cells in patients with bone sarcomas: an observational study
Study objectivesThe 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) studiedSpecialty: Cancer, Primary sub-specialty: Sarcoma; UKCRC code/ Disease: Cancer/ Malignant neoplasms of bone and articular cartilage
InterventionParticipants 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 typeOther
Primary outcome measureEnumeration 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 measures1. 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 date01/05/2014
Completion date31/03/2022

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 30; UK Sample Size: 30
Key inclusion criteria1. 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 criteria1. 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 enrolment07/04/2015
Date of final enrolment31/07/2017

Locations

Countries of recruitment

  • England
  • Scotland
  • United Kingdom

Study participating centres

Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Royal Hospital for Sick Children
9 Sciennes Road
Edinburgh
EH9 1LF
United Kingdom
University College London Hospitals
Cancer Clinical Trials Unit
1st Floor East
250 Euston Road
London
NW1 2PG
United Kingdom
Birmingham Children’s Hospital
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Sponsor information

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Hospital/treatment centre

Freeman Hospital
Freeman Road
High Heaton
Newcastle-Upon-Tyne
NE7 7DN
England
United Kingdom

ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Charity

Bone Cancer Research Trust

No information available

Children with Cancer UK

No information available

Results and Publications

Intention to publish date31/03/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication date in a high-impact peer reviewed journal.
IPD sharing planThe 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.