Methylation analysis for soft tissue lesions and rapid classification
| ISRCTN | ISRCTN52235823 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52235823 |
| IRAS number | 353961 |
| Secondary identifying numbers | 25015 |
- Submission date
- 14/05/2025
- Registration date
- 21/05/2025
- Last edited
- 20/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
To find out the cause, soft tissue lumps are often investigated with a biopsy or removal of the lump and examination of the cells under a microscope. However, in some cases, diagnosis is challenging based upon the appearance of the cells alone. In these cases, DNA testing to find out the genetic make-up of the lump may be requested by doctors. However, currently, the results of DNA tests can take weeks or months to be available, delaying diagnosis. In this study, we wish to test the accuracy and reliability of a novel genetic (DNA) test which may diagnose and classify soft tissue lumps more rapidly than conventional NHS practice. If this is successful, this could reduce the delays sometimes experienced by patients and hopefully improve treatment and outcomes.
Who can participate?
Adults with a soft tissue lump requiring either biopsy or surgical excision will be invited to take part.
What does the study involve?
In this study, we wish to collect a sample of tissue from participants undergoing biopsy or surgery of a soft tissue lump, for additional DNA analysis. Participants will not need to attend any additional appointments or visits with the research team.
What are the possible benefits and risks of participating?
There will be no direct benefit to participants from taking part, but the information we get from this study may help diagnose soft tissue lumps more quickly and easily in future. This may help us to identify treatments for patients and improve outcomes for patients going forward. At present, the analysis performed as part of this study is for research use only, and as such, cannot be used by the clinical team or benefit clinical care. As no separate, standalone, additional interventions or procedures are planned in this study, the risks of taking part are minimal. For participants having tissue samples taken during a biopsy procedure, they may feel more discomfort or pain during the procedure as two additional passes will need to be taken by the radiologist.
Where is the study run from?
This research is being managed by the University of Nottingham.
When is the study starting and how long is it expected to run for?
This study is expected to start recruitment in July 2025, and run until June 2027.
Who is funding the study?
This research is being funded by the National Institute of Health and Care Research Biomedical Research Centre, Nottingham.
Who is the main contact?
Name: Mr. Christopher Deacon
Email: christopher.deacon@nottingham.ac.uk
Contact information
Public
Department of Academic Orthopaedics
C floor, West Block
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0001-6975-8010 |
|---|---|
| Phone | +44 115 82 31113 |
| christopher.deacon@nottingham.ac.uk |
Scientific, Principal Investigator
Room D132 Queens Medical Centre
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
| ORCID ID |
0000-0002-5264-0929 |
|---|---|
| Phone | +44 115 82 30358 |
| matt.loose@nottingham.ac.uk |
Study information
| Study design | Single-centre prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital, Laboratory, University/medical school/dental school |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Nanopore-based methylome classification and next-day comprehensive tumour profiling for ultra-rapid tumour diagnostics in soft-tissue sarcomas |
| Study acronym | MASTERClass |
| Study objectives | The main purpose of this study is to demonstrate the feasibility of a novel nanopore-based adaptive targeting protocol for methylation-based sarcoma classification, in parallel with long-read SNV, fusion and CNV analysis. Primary endpoint comparison will be against current standard-of-care histopathological assessment, as per standard NHS clinical practice. The hypothesis of this study is that methylation analysis provides accurate diagnosis and classification comparable to current standard-of-care techniques. |
| Ethics approval(s) |
Approved 12/05/2025, Nottingham 2 REC (Health Research Authority, 2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 207 104 8009; nottingham2.rec@hra.nhs.uk), ref: 25/EM/0096 |
| Health condition(s) or problem(s) studied | Diagnosis of sarcoma in adults |
| Intervention | Participants will have one tissue sample collected, either from an additional core biopsy taken at the time of diagnosis, or via sampling of the surgically resected lesion at the time of its excision. Tumour DNA methylome analysis will be performed in parallel with long-read SNV, fusion and CNV analysis, using the PromethION platform (Oxford Nanopore Technologies, Oxford, UK). |
| Intervention type | Genetic |
| Primary outcome measure | Percentage of sarcoma diagnoses correctly predicted by methylation-based classification, at 12 months post-biopsy or surgery |
| Secondary outcome measures | Percentage of sarcomas in which known pathognomonic molecular features are correctly identified by nanopore long-read sequencing, at 12 months post-biopsy or surgery |
| Overall study start date | 10/12/2024 |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Considered to have sarcomatous soft-tissue lesion requiring biopsy or surgical excision 2. A good comprehension of the English language 3. Age ≥18 years old 4. Ability to give informed consent |
| Key exclusion criteria | 1. Patients in which the usual care team believe the lesion to have low risk of malignancy (i.e., most likely a benign lesion based on clinical history, examination and investigation findings) |
| Date of first enrolment | 20/06/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Derby Road
Nottingham
NG7 2UH
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Nottingham
NG7 2RD
United Kingdom
Sponsor information
University/education
University of Nottingham
University Park
Nottingham
NG7 2RD
England
United Kingdom
| Phone | +44 115 951 5151 |
|---|---|
| sponsor@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | No identifiable data will be used when publishing results. Results will be presented at local and international meetings related to sarcoma diagnosis, genetics, and biotechnology, and published in appropriate peer-reviewed journals. Funding bodies and contributors will be acknowledged in publications arising from the study. We aim to present and publish the results of this research within 2 years of study completion. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
20/06/2025: The recruitment start date was changed from 01/07/2025 to 20/06/2025.
14/05/2025: Trial's existence confirmed by NHS HRA.
