Use of Hair to Diagnose the Presence of Breast Cancer

Fermiscan

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Procedure: diagnosis of breast cancer by x-ray diffraction of hair

Study type

Interventional

Funder types

Industry

Identifiers

NCT00419900

FER2k

Details and patient eligibility

About

Using synchrotron X-ray diffraction, it has been reported that a hair from an individual with breast cancer exhibits a difference in its molecular structure compared to that of an individual without breast cancer. This difference is visible in the X-ray diffraction pattern as a ring superimposed on the pattern for normal hair.

The hypothesis of this study is that synchrotron x-ray diffraction can be used to differentiate hairs from women with medically diagnosed breast cancer from women not known to have the disease.

To test this hypothesis, hair from 2000 women attending radiology clinics for mammography will be collected, analysed by x-ray diffraction and then analysed using Fermiscan proprietary image analysis software. The mammogram status of the subjects will be blinded from the diffraction analysts. Results will then be compared with mammography results to allow a direct comparison between the Fermiscan test and mammography in terms of specificity and sensitivity.

Sex

Female

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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 and/or pubic hair

Exclusion criteria

Women who have dyed or permed their scalp hair within the previous 6 weeks and whose pubic hair is unavailable;
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.