Earlier detection of breast cancer using a blood test and Raman spectroscopy
| ISRCTN | ISRCTN12224189 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12224189 |
| IRAS number | 319524 |
| Secondary identifying numbers | IRAS 319524, CPMS 56288 |
- Submission date
- 04/07/2023
- Registration date
- 24/08/2023
- Last edited
- 20/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Breast cancer is the most common cancer in the UK. 15 out of 100 newly diagnosed cancers in the UK are breast cancers. Survival for breast cancer is generally good, especially if a patient is diagnosed early. The benefits of finding breast cancer early are clear and often result in requiring less treatment with a greater likelihood of cure. Symptoms of breast cancer include a lump that can be felt, skin/nipple changes and nipple discharge. If patients already have symptoms, they are usually referred to a one-stop breast clinic. This is where a patient will have the gold standard investigation which includes several tests known as ‘triple assessment’. Patients will have an examination of their breasts alongside imaging (x-ray mammogram or ultrasound), and a tissue sample (biopsy) is taken if these tests reveal an abnormal area. The aim of this project is to develop a blood test that can detect breast cancer cells, and also the type of breast cancer earlier than we can at present. Raman spectroscopy uses a laser to excite the chemical signals in a blood sample to create a fingerprint of that sample. If breast cancer features are present, the breast cancer fingerprint can then be analysed to provide information on treatment strategy. Ultimately, this technique would allow earlier diagnosis and may help patients to start treatment sooner than is possible currently. The addition of a cancer-specific test such as Raman to the urgent suspected breast cancer referral pathways could increase the probability of breast cancer being confirmed in patients who are referred to clinics. This could assist with more effective triage of patients to breast clinics, particularly with current levels of high demand.
Who can participate?
Women aged over 18 years old with a confirmed diagnosis of breast cancer and a control group of women with a benign outcome after assessment from a specialist breast triple assessment clinic
What does the study involve?
This study will recruit symptomatic patients who are referred to specialist breast services with suspicion of breast cancer. The study seeks to obtain blood samples for analysis using spectroscopy in vitro diagnostic devices. Outcomes from specialist breast clinics (cancer/normal assessment findings) will be used to train and test a machine learning algorithm to allow calculation of the sensitivity and specificity of the device.
What are the possible benefits and risks of participating?
This research will investigate if the cause of a breast lump (including cancer) can be diagnosed by a simple blood test. Early diagnosis before symptoms develop is vital for the best outcome. Current screening tests can be invasive and unpleasant, so alternative tests are needed. There is potential for patient benefit from this original research, which includes easier detection by a blood test and the ability to monitor response to treatment. There are small risks involved with taking a blood sample. These include bruising, bleeding, pain/discomfort and infection at the local site from which the blood is taken.
Where is the study run from?
Swansea Bay University Health Board (UK)
When is the study starting and how long is it expected to run for?
August 2022 to August 2024
Who is funding the study?
Cancer Research Wales (UK)
Who is the main contact?
Prof Dean Harris, dean.a.harris@wales.nhs.uk (UK)
Contact information
Principal Investigator
Swansea Bay University Health Board
1 Talbot Gateway
Baglan Energy Park
Baglan
Port Talbot
Swansea
SA12 7BR
United Kingdom
 ORCID ID |
0000-0003-2673-8946 |
|---|---|
| Phone | +44 (0)1792285459 |
| dean.a.harris@wales.nhs.uk |
Scientific
Swansea Bay University Health Board
1 Talbot Gateway
Baglan Energy Park
Baglan
Port Talbot
Swansea
SA12 7BR
United Kingdom
| ORCID ID |
0000-0003-3831-8594 |
|---|---|
| Phone | +44 (0)1792 285459 |
| imran.mohamed@wales.nhs.uk |
Study information
| Study design | Prospective multi-site observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format |
| Scientific title | Prospective multi-site observational cohort study of serum Raman spectroscopy and supervised machine learning in the detection of breast cancer |
| Study acronym | BrCa-SPECT |
| Study objectives | The aim of this project is to develop a blood test that can detect breast cancer cells, and also the type of breast cancer earlier than we can at present. Raman spectroscopy uses a laser to excite the chemical signals in a blood sample to create a fingerprint of that sample. If breast cancer features are present, the breast cancer fingerprint can then be analysed to provide information on treatment strategy. Ultimately, this technique would allow earlier diagnosis and may help patients to start treatment sooner than is possible currently. |
| Ethics approval(s) |
Approved 15/05/2023, South West - Cornwall & Plymouth Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44 (0)2071048071; cornwallandplymouth.rec@hra.nhs.uk), ref: 23/SW/0046 |
| Health condition(s) or problem(s) studied | Breast cancer detection |
| Intervention | The study involves taking a blood test (approximately one tablespoon of blood) for analysis. Participants will be asked to participate in the study by signing and initialling a consent form. The blood test can then be collected by a researcher experienced in blood sampling. Participants will be required to fast before the blood test is taken (i.e. no food and only clear fluids for up to 4 hours before the blood test). There is no further action needed by participants. The results from the blood test will not affect clinical care as it is a research tool only. The primary outcome will establish the performance of the Raman spectroscopy analysis system for the detection of breast neoplasia (1. Ductal carcinoma-in-situ and 2. Invasive carcinoma) in its intended population (symptomatic patients referred to tertiary breast services undergoing triple assessment) through outcome measures of test sensitivity and specificity. |
| Intervention type | Not Specified |
| Primary outcome measure | Test sensitivity and specificity measured using outcomes from specialist breast clinics (cancer/normal assessment findings) to train and test a machine learning algorithm at one timepoint |
| Secondary outcome measures | 1. To determine an association between modes of presentation/symptomatology of breast cancer measured using Raman spectroscopy at one timepoint 2. To determine an association between breast cancer / pre-malignant conditions (DCIS) measured using Raman spectroscopy at one timepoint |
| Overall study start date | 01/08/2022 |
| Completion date | 31/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Aged 18 years old or over 2. Confirmed histopathological diagnosis of breast cancer OR benign outcome after assessment from specialist breast triple assessment clinic (control group) 3. Willing to provide informed consent for study participation 4. Able and willing to provide blood serum samples |
| Key exclusion criteria | 1. Male sex (majority of patients with breast cancer are female and the study is unlikely to recruit a sufficient number of male patients to provide a representative sample that could be compared between sexes) 2. Under the age of 18 years old 3. Unwilling/unable to consent to trial participation Patients from vulnerable groups (defined as lacking capacity to freely give informed consent) Unwilling/unable to provide blood samples required for the study. |
| Date of first enrolment | 01/11/2023 |
| Date of final enrolment | 01/09/2024 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
Baglan Energy Park
Baglan
Port Talbot
Swansea
SA12 7BR
United Kingdom
Pontyclun
CF72 8XR
United Kingdom
Abergavenny
NP7 7EG
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development
Floor 1, ILS2
Swansea University
Singleton Park
Swansea
SA2 8PP
Wales
United Kingdom
| Phone | +44 (0)1792280889 |
|---|---|
| anne-claire.owen@wales.nhs.uk | |
| Website | https://www.abm.wales.nhs.uk/ |
"ROR" |
https://ror.org/04zet5t12 |
Funders
Funder type
Research organisation
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Ymchwil Canser Cymru, CRW
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be made available upon request from the Chief Investigator, Prof. Dean Harris (dean.a.harris@wales.nhs.uk). Informed consent from participants was required and obtained. Only pseudonymised data relevant to the study is shared with researchers. All identifiable data is held by their routine clinical care team/NHS research team recruiting the patient. Any identifiable data especially relating to medical records and genetic data will not be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
20/09/2023: A link to the HRA research summary was added.
11/09/2023: The recruitment start date was changed from 01/09/2023 to 01/11/2023.
21/07/2023: Trial's existence confirmed by Health Research Authority (HRA) and Health and Care Research Wales (HCRW) (UK)
