Earlier detection of breast cancer using a blood test and Raman spectroscopy

Not Applicable

• Conditions: Breast cancer detection; Not Applicable

• Registration Number: ISRCTN12224189
• Lead Sponsor: Swansea Bay University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-24
• Last Update Posted: 3 October 2023
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 300

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. To determine an association between modes of presentation/symptomatology of breast cancer measured using Raman spectroscopy at one timepoint<br>2. To determine an association between breast cancer / pre-malignant conditions (DCIS) measured using Raman spectroscopy at one timepoint