NCT00390377

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 Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
Last Updated

October 19, 2006

Status Verified

October 1, 2006

First QC Date

October 17, 2006

Last Update Submit

October 18, 2006

Conditions

Breast Cancer

Keywords

x-ray diffractionhairbreast cancersynchrotron

Interventions

Cutting scalp hairPROCEDURE

Eligibility Criteria

Age20 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult women (aged \>20) who are undergoing mammography, and
  • Who are willing and able to provide informed consent; and
  • Who have usable scalp hair

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George Private Hospital

Sydney, New South Wales, 2217, Australia

RECRUITING

Related 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. doi: 10.1002/ijc.20824.

    PMID: 15645416BACKGROUND

  • 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.

    PMID: 10078527BACKGROUND

  • 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.

    PMID: 11390537BACKGROUND

  • 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.

    PMID: 12587913BACKGROUND

  • 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.

    PMID: 1289498BACKGROUND

  • 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.

    PMID: 12529353BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ronald Shnier, MBBS, FRACR

    Symbion Health

    PRINCIPAL INVESTIGATOR

  • Gary Corino, BSc

    Fermiscan Ltd

    STUDY DIRECTOR

Central Study Contacts

Peter W French, BSc, MSc, PhD

CONTACT

+61292454460pfrench@fermiscan.com.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 19, 2006

Study Start

October 1, 2006

Last Updated

October 19, 2006

Record last verified: 2006-10

Locations

AU(1)