Use of Hair to Diagnose Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2006 by Fermiscan Ltd.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Fermiscan Ltd

ClinicalTrials.gov Identifier:

NCT00390377

First received: October 17, 2006

Last updated: October 18, 2006

Last verified: October 2006

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Single Primary Purpose: Diagnostic
Official Title:	A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer X-Rays

U.S. FDA Resources

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 (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.

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..


ClinicalTrials.gov Identifier:	NCT00390377 History of Changes
Other Study ID Numbers:	FT240-2006
Study First Received:	October 17, 2006
Last Updated:	October 18, 2006

Keywords provided by Fermiscan Ltd:


x-ray diffraction hair breast cancer synchrotron

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

ClinicalTrials.gov processed this record on September 21, 2017

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