Use of Hair to Diagnose Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00390377
• Other study ID #: FT240-2006
• Status: Recruiting
• Phase: Phase 2
• First received: October 17, 2006
• Last updated: October 18, 2006
• Start date: October 2006

Study information

• Verified date: October 2006
• Source: Fermiscan Ltd
• Contact: Peter W French, BSc, MSc, PhD
• Phone: +61292454460
• Email: pfrench[@]fermiscan.com.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Cutting scalp hair

Locations

Country	Name	City	State
Australia	St George Private Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Fermiscan Ltd

Country where clinical trial is conducted

Australia, 

References & Publications (6)

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. — View Citation

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. — View Citation

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.. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation