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A study for the future development of an early-stage breast cancer detection test

A non-interventional, proof of concept study to collect blood samples from patients with stage 0-II breast cancer and from healthy participants to measure plasma biomarkers for future development of an early-stage breast cancer detection test

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN18266384
Enrollment
40
Registered
2026-05-28
Start date
2026-04-13
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Stage 0-II breast cancer Cancer

Interventions

This study is non-interventional and will be conducted at primary care GP NHS sites in the UK only. Screening procedures include informed consent, a review of participant medical history, smoking hist

Sponsors

Faster dignostics Ltd
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 71 Years

Inclusion criteria

Inclusion criteria: Breast Cancer Participants Group: 1. Females aged =50 years to =71 years of age, inclusive at time of consent. 2. Breast cancer participants: diagnosed with breast cancer stage 0 to II post biopsy and mammogram screening 3. Breast cancer participants: treatment naïve participants only, diagnosed by biopsy and mammogram 4. Breast cancer participants: primary cancer donors only Healthy Participant Group: 1. Females aged =50 years to =71 years of age, inclusive at time of consent. 2. Healthy volunteer participants: no current or prior diagnosis of any cancer 3. Healthy volunteer participants: not currently under investigation for any suspected malignancy 4. Healthy volunteer participants: no current symptoms suggestive of breast pathology (e.g., palpable lump, nipple discharge, skin changes)

Exclusion criteria

Exclusion criteria: 1. HIV/HBV/HCV positive, as determined by rapid strip test 2. Women who are pregnant, or lactating 3. Recent receipt of a vaccine within 90 days or five half-lives, whichever is longer 4. Participants in receipt of HRT 5. Participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure within 90 days or five half-lives, whichever is longer, prior to consent or planned participation in such a study during the period of this clinical study 6. Receipt of immunoglobulins, blood or blood-derived products within 90 days prior to consent 7. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or study completion 8. Current alcohol abuse or drug addiction (reported or suspected) 9. Identified as an Investigator or employee of the Investigator or study centercentre with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. (i.e., in the employment of the clinical study sites) 10. Participants receiving any of the following medications: 10.1. Thyroid Replacement Therapy: Levothyroxine sodium for the management of hypothyroidism 10.2. Metformin for glycaemic control 10.3. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including, but not limited to, Ibuprofen or Naproxen

Countries

England, United Kingdom

Contacts

Public ContactSimon Duncan
info@fasterdiagnostics.com+44 2039303177

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026