Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Screening Active 20 and over Pharmaceutical / Industry FER2k NCT00419900

Trial Description

Summary

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.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Fermiscan Limited

Phillip Yuile, MBBS, FRACR

Principal Investigator

Peter W French, BSc, MSc, PhD		Ph: +61292454460
		Email: pfrench@fermiscan.com.au

Gary Corino, BSc		Ph: +61292454460
		Email: gcorino@fermiscan.com.au

Australia
New South Wales
	Sydney
	Bankstown - Lidcombe Hospital
	Cancer Therapy Centre at Campbelltown Hospital
	Cancer Therapy Centre at Liverpool Hospital
	Penrith Imaging
	St. George Private Hospital

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00419900
Information obtained from ClinicalTrials.gov on May 27, 2008