NCT00419900

Brief Summary

Using synchrotron X-ray diffraction, it has been reported that a hair from an individual with breast cancer exhibits a difference in its molecular structure compared to that of an individual without breast cancer. This difference is visible in the X-ray diffraction pattern as a ring superimposed on the pattern for normal hair. The hypothesis of this study is that synchrotron x-ray diffraction can be used to differentiate hairs from women with medically diagnosed breast cancer from women not known to have the disease. To test this hypothesis, hair from 2000 women attending radiology clinics for mammography will be collected, analysed by x-ray diffraction and then analysed using Fermiscan proprietary image analysis software. The mammogram status of the subjects will be blinded from the diffraction analysts. Results will then be compared with mammography results to allow a direct comparison between the Fermiscan test and mammography in terms of specificity and sensitivity.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_1 breast-cancer

Geographic Reach
1 country

5 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
Last Updated

January 9, 2007

Status Verified

January 1, 2007

First QC Date

January 7, 2007

Last Update Submit

January 7, 2007

Conditions

Breast Cancer

Keywords

breast cancerdiagnosisx-ray diffractionsynchrotronhair

Outcome Measures

Primary Outcomes (1)

  • Accuracy (sensitivity and specificity) of the breast cancer test based on detection of an abnormal pattern of hair x-ray diffraction compared to the gold standard of mammography plus biopsy where indicated

Secondary Outcomes (1)

  • The prevalence of a positive hair x-ray diffraction pattern and a negative mammogram; and the prevalence of a negative hair x-ray diffraction pattern and a positive mammogram;

Interventions

diagnosis of breast cancer by x-ray diffraction of hairPROCEDURE

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
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 and/or pubic hair

You may not qualify if:

  • Women who have dyed or permed their scalp hair within the previous 6 weeks and whose pubic hair is unavailable;
  • 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 (5)

Bankstown Diagnostic Imaging Centre

Sydney, New South Wales, 2200, Australia

RECRUITING

Campbelltown Ultrascan Radiology

Sydney, New South Wales, Australia

RECRUITING

Diagnostic Imaging Centre, St George Private Hospital

Sydney, New South Wales, Australia

RECRUITING

Liverpool Ultrascan Radiology

Sydney, New South Wales, Australia

RECRUITING

Penrith Imaging

Sydney, New South Wales, Australia

RECRUITING

Related Publications (5)

  • James VJ. A place for fiber diffraction in the detection of breast cancer? Cancer Detect Prev. 2006;30(3):233-8. doi: 10.1016/j.cdp.2006.04.001. Epub 2006 Jul 28.

    PMID: 16876335BACKGROUND

  • 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. 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

  • 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 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

MeSH Terms

Conditions

Breast NeoplasmsDisease

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Phillip Yuile, MBBS, FRACR

    Radiation Oncology Associates, Sydney, Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter W French, BSc, MSc, PhD

CONTACT

+61292454460pfrench@fermiscan.com.au

Gary Corino, BSc

CONTACT

+61292454460gcorino@fermiscan.com.au

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2007

First Posted

January 9, 2007

Study Start

December 1, 2006

Last Updated

January 9, 2007

Record last verified: 2007-01

Locations

AU(5)