NCT00390377UnknownPhase 2
A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.
Fermiscan Ltd2 sites in 1 country240 target enrollmentStarted: October 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 240
- Locations
- 2
Study Overview
Brief Summary
This study aims to perform x-ray diffraction analysis of blinded hair samples from women with a documented health status, to validate the previous findings of James et al who described that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects from those of diseased subjects, specifically those suffering from breast cancer.
The primary hypothesis is that x-ray diffraction of hair can be used to distinguish hair from patients with confirmed breast cancer from subjects without detectable breast cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Single
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult women (aged >20) who are undergoing mammography, and
- •Who are willing and able to provide informed consent; and
- •Who have usable scalp hair
Exclusion Criteria
- •Women with a history of breast cancer ever or other cancers (excluding non-melanoma skin cancer and CIN: cervical intra-epithelial neoplasia) within 5 years.
Investigators
Study Sites (2)
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