Condition category
Cancer
Date applied
05/06/2017
Date assigned
26/06/2017
Last edited
24/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review with external organisation

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 measures

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

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

Sponsor information

Organisation

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Editorial Notes

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.