Trial details imported from

For full trial details, please see the original record at

Trial ID
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Use of Hair to Diagnose Breast Cancer
Scientific title
A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Surgery - Cutting scalp hair

Treatment: Surgery: Cutting scalp hair

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group


Key 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
Minimum age
20 Years
Maximum age
No limit
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St George Private Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Fermiscan Ltd

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
James V, Corino G, Robertson T, Dutton N, Halas D, Boyd A, Bentel J, Papadimitriou J. Early diagnosis of breast cancer by hair diffraction. Int J Cancer. 2005 May 10;114(6):969-72.
James V, Kearsley J, Irving T, Amemiya Y, Cookson D. Using hair to screen for breast cancer. Nature. 1999 Mar 4;398(6722):33-4.
Meyer P, James VJ. Experimental confirmation of a distinctive diffraction pattern in hair from women with breast cancer. J Natl Cancer Inst. 2001 Jun 6;93(11):873-5.
James VJ. The traps and pitfalls inherent in the correlation of changes in the fibre diffraction pattern of hair with breast cancer. Phys Med Biol. 2003 Jan 21;48(2):L5-9; discussion L11-3.
Kimura M, Tanaka N, Kimura Y, Miyake K, Kitaura T, Fukuchi H. Pharmacokinetic interaction of zonisamide in rats. Effect of other antiepileptics on zonisamide. J Pharmacobiodyn. 1992 Nov;15(11):631-9.
James V. False-positive results in studies of changes in fiber diffraction of hair from patients with breast cancer may not be false. J Natl Cancer Inst. 2003 Jan 15;95(2):170-1. Erratum in: J Natl Cancer Inst. 2003 Feb 19;95(4):334..
Public notes

Principal investigator
Name 0 0
Ronald Shnier, MBBS, FRACR
Address 0 0
Symbion Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter W French, BSc, MSc, PhD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries