Use of Hair to Diagnose the Presence of Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Fermiscan Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fermiscan Ltd
ClinicalTrials.gov Identifier:
NCT00419900
First received: January 7, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: diagnosis of breast cancer by x-ray diffraction of hair
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Screening

Resource links provided by NLM:


Further study details as provided by Fermiscan Ltd:

Primary Outcome Measures:
  • 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:
  • 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;

Estimated Enrollment: 2000
Study Start Date: December 2006
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 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.
  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: NCT00419900

Contacts
Contact: Peter W French, BSc, MSc, PhD +61292454460 pfrench@fermiscan.com.au
Contact: Gary Corino, BSc +61292454460 gcorino@fermiscan.com.au

Locations
Australia, New South Wales
Bankstown Diagnostic Imaging Centre Recruiting
Sydney, New South Wales, Australia, 2200
Diagnostic Imaging Centre, St George Private Hospital Recruiting
Sydney, New South Wales, Australia
Liverpool Ultrascan Radiology Recruiting
Sydney, New South Wales, Australia
Campbelltown Ultrascan Radiology Recruiting
Sydney, New South Wales, Australia
Penrith Imaging Recruiting
Sydney, New South Wales, Australia
Sponsors and Collaborators
Fermiscan Ltd
Investigators
Principal Investigator: Phillip Yuile, MBBS, FRACR Radiation Oncology Associates, Sydney, Australia