Use of Hair to Diagnose the Presence of Breast Cancer

January 7, 2007 updated by: Fermiscan Ltd

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2000

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2200
        • Recruiting
        • Bankstown Diagnostic Imaging Centre
      • Sydney, New South Wales, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 and/or pubic hair

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fermiscan Ltd

Investigators

  • Principal Investigator: Phillip Yuile, MBBS, FRACR, Radiation Oncology Associates, Sydney, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Registration Dates

First Submitted

January 7, 2007

First Submitted That Met QC Criteria

January 7, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

January 9, 2007

Last Update Submitted That Met QC Criteria

January 7, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER2k

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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