Fingertip smears for breast cancer diagnosis
Research type
Research Study
Full title
Fingertip smear screening for breast cancer
IRAS ID
253281
Contact name
Lynda Wyld
Contact email
Sponsor organisation
Doncaster and Bassetlaw Teaching Hospitals NHS FT
Clinicaltrials.gov Identifier
0839/2018/NCTS, Sponsor R and D number
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
In 2014 approximately 55,200 new cases of breast cancer were diagnosed in the UK, making it the most common cancer in British women1. Globally, it is estimated to affect over 1.7 million women and cause over 500 000 deaths each year2.
Mammography is the gold standard for diagnostic imaging and screening, whereas biopsies confirm the diagnosis and allow assessment of tumour biology. Advanced (metastatic) disease is usually diagnosed, and monitored, with serial CT scans. A core biopsy, at metastatic diagnosis, is often performed to confirm and characterise disease biology. Whilst effective, these current tests expose individuals to radiation, have limitations to their sensitivity and specificity and may cause pain, anxiety and the risk of bleeding. Some women find exposure of their breasts for mammography culturally unacceptable and decline screening or delay symptomatic presentation as a result. Therefore, there is the need for further technological developments for non-invasive and rapid tests for screening, diagnostic and monitoring purposes.
The project intends to evaluate the role of mass spectrometry of fingertip smears in the screening, diagnosis and monitoring of breast cancer. The technique will measure fingertip exocrine secretions from patients with and without breast cancer to attempt to detect a specific pattern of oncological molecular markers to enable the discrimination of healthy versus breast cancer patients. Matrix Assisted Laser Desorption Ionisation Mass Spectrometry (MALDI MS) will be employed to recover cancer signatures, assisted by statistical modelling to discriminate oncological versus healthy patients and thus determining the specificity and sensitivity of this technique.
The study will recruit approximately 200 patients, 80 with advanced breast cancer, 80 with newly diagnosed breast cancer and 40 health controls from clinics in the North Trent region (Doncaster, Bassetlaw, Sheffield and Barnsley) which between them see ~1300 new cancers per year. Women will be invited to give 20 fingertip smears, two from each finger after cleaning their fingers with dilute alcohol solution and then waiting for 15 minutes for fresh secretions to re-form. The smears are completely painless and just involve gently pressing the finger-tips onto a specially made aluminium slide. The process takes about 20 minutes altogether. Samples will then be transferred in dry ice to the Mass Spectrometry laboratory in Sheffield for analysis. A set of anonymised patient data about their cancer characteristics will also be collected to allow data interpretation.
This is an early phase exploratory study to establish whether this technology has the potential for clinical use and as such the results have no current clinical value to the patients, who will not be made aware of their results.REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/1792
Date of REC Opinion
29 Oct 2018
REC opinion
Further Information Favourable Opinion