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Use of Hair to Diagnose Breast Cancer

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Cutting scalp hair

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring x-ray diffraction, hair, breast cancer, synchrotron

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)Female

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.

Sites / Locations

St George Private HospitalRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00390377

First Posted

October 17, 2006

Last Updated

October 18, 2006

Sponsor

Fermiscan Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00390377

Brief Title

Use of Hair to Diagnose Breast Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Unknown status

Study Start Date

October 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Fermiscan Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

x-ray diffraction, hair, breast cancer, synchrotron

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Non-Randomized

Enrollment

240 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Cutting scalp hair

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter W French, BSc, MSc, PhD

Phone

+61292454460

pfrench@fermiscan.com.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Shnier, MBBS, FRACR

Organizational Affiliation

Symbion Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gary Corino, BSc

Organizational Affiliation

Fermiscan Ltd

Official's Role

Study Director

Facility Information:

Facility Name

St George Private Hospital

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronald Shnier, MBBS, FRACR

12. IPD Sharing Statement

Citations:

PubMed Identifier

15645416

Citation

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. doi: 10.1002/ijc.20824.

Results Reference

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PubMed Identifier

10078527

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. doi: 10.1038/17949. No abstract available.

Results Reference

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PubMed Identifier

11390537

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. doi: 10.1093/jnci/93.11.873. No abstract available.

Results Reference

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PubMed Identifier

12587913

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. doi: 10.1088/0031-9155/48/2/101.

Results Reference

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PubMed Identifier

1289498

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. doi: 10.1248/bpb1978.15.631.

Results Reference

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PubMed Identifier

12529353

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. doi: 10.1093/jnci/95.2.170. No abstract available. Erratum In: J Natl Cancer Inst. 2003 Feb 19;95(4):334.

Results Reference

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Use of Hair to Diagnose Breast Cancer

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