BrCa-SPECT

• Research type

  Research Study

• Full title

  Blood Raman spectroscopy and breast cancer: towards early diagnosis and personalised medicine

• IRAS ID

  319524

• Contact name

  Dean Harris

• Contact email

  dean.a.harris@wales.nhs.uk

• Sponsor organisation

  Swansea Bay University Health Board

• Duration of Study in the UK

  1 years, 4 months, 1 days

• Research summary

  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 of investigation which includes several tests known as ‘triple assessment’. Patients will have an examination of their breast 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.

  Method
  This study will recruit symptomatic patients who are referred to specialist breast services with suspicion of breast cancer.

  Phase 1
  360 blood sample analyses.

  300 serum samples will be obtained from 150 patients with breast cancer & 150 propensity matched (for age) controls with benign disease

  The machine learning model will be tested with a further 20% of the original sample (i.e. 60 patients)

  All samples from patients with breast cancer will be imported from the Raman-CRC study (IRAS 146942); group 7 non-colorectal cancer group. This includes a combination of samples that have been analysed and those that require analysis.
  Patients in Group 7 have provided informed consent for their medical records and blood samples to be used (REC ID: 14/WA/0028).

  The control samples with benign disease will be recruited prospectively.

  Phase 2
  External validation of machine learning model with a further 100 patients to be prospectively collected

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  23/SW/0046

• Date of REC Opinion

  15 May 2023

• REC opinion

  Further Information Favourable Opinion