Breast Cancer Early Detection: Nipple Aspirate Fluid (BRACELET-NAF)
Research type
Research Study
Full title
BREAST CANCER EARLY DETECTION: NIPPLE ASPIRATE FLUID (BRACELET-NAF) - A FEASIBILITY STUDY
IRAS ID
348291
Contact name
Niki Flaum
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Nipple aspirate fluid (NAF) is the physiological fluid present in the breast ductal system. The majority of breast cancers are invasive ductal carcinomas, arising from the epithelial lining of terminal ducts where NAF is produced. It is possible therefore that NAF could be used to detect early breast cancer, potentially before it has grown to the extent that it is detectable by mammography or by examination. It has the potential to assist reducing misdiagnosis related to mammography screening, which has significant psychological impact as well as consequences in terms of further investigations and potential surgery/treatment. There is potential use also to widen access to screening.
We plan to recruit 10 healthy women to donate NAF samples. These samples will be used within this pilot study to establish a workflow of collection, analysis and storage of NAF. If samples are successfully analysed they will be used as subsequent controls within a further study.
Women will be recruited through advertising to women seen through the New Patient Clinic at the Nightingale Centre at Wythenshawe Hospital who are assessed for a breast concern and found to have no concerning features following examination and imaging. Following reviewing a Patient Information Sheet and nasal oxytocin information for a minimum of 24 hours they will undergo NAF collection and answer a brief questionnaire regarding the acceptability of the procedure. Samples will be transported to and stored in the National Biomarker Centre at the Paterson Building, University of Manchester. We will assess volume collected and if we can detect cell-free DNA, mutant allele fraction, as well as related tests such as methylation studies. In addition to establishing feasibility, samples collected will be available and stored for further study of other biomarkers (e.g. proteins, extracellular vesicles).
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
25/NW/0066
Date of REC Opinion
8 Apr 2025
REC opinion
Further Information Favourable Opinion