Use of Hair to Diagnose Breast Cancer - Full Text View

Sponsored by:	Fermiscan Ltd
Information provided by:	Fermiscan Ltd
ClinicalTrials.gov Identifier:	NCT00390377

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Procedure: Cutting scalp hair	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer X-Rays

Drug Information available for: X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.

Further study details as provided by Fermiscan Ltd:

Estimated Enrollment:	240
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390377

Contacts

Contact: Peter W French, BSc, MSc, PhD

+61292454460

pfrench@fermiscan.com.au

Locations

Australia, New South Wales
St George Private Hospital	Recruiting
Sydney, New South Wales, Australia, 2217
Principal Investigator: Ronald Shnier, MBBS, FRACR

Sponsors and Collaborators

Fermiscan Ltd

Investigators

Principal Investigator:	Ronald Shnier, MBBS, FRACR	Symbion Health
Study Director:	Gary Corino, BSc	Fermiscan Ltd

More Information

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. No abstract available.

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. No abstract available.

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. No abstract available. Erratum in: J Natl Cancer Inst. 2003 Feb 19;95(4):334.

Study ID Numbers:	FT240-2006
Study First Received:	October 17, 2006
Last Updated:	October 18, 2006
ClinicalTrials.gov Identifier:	NCT00390377
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Fermiscan Ltd:

x-ray diffraction
hair
breast cancer
synchrotron

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009