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

Prospective multi-site observational cohort study of serum Raman spectroscopy and supervised machine learning in the detection of breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12224189
Enrollment
300
Registered
2023-08-24
Start date
2023-11-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer detection Other

Interventions

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

Sponsors

Swansea Bay University Health Board
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 120 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026