Use of Hair to Diagnose Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390377
Recruitment Status : Unknown
Verified October 2006 by Fermiscan Ltd.
Recruitment status was:  Recruiting
First Posted : October 19, 2006
Last Update Posted : October 19, 2006
Information provided by:
Fermiscan Ltd

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Cutting scalp hair Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390377

Contact: Peter W French, BSc, MSc, PhD +61292454460

Australia, New South Wales
St George Private Hospital Recruiting
Sydney, New South Wales, Australia, 2217
Principal Investigator: Ronald Shnier, MBBS, FRACR         
Sponsors and Collaborators
Fermiscan Ltd
Principal Investigator: Ronald Shnier, MBBS, FRACR Symbion Health
Study Director: Gary Corino, BSc Fermiscan Ltd

Publications: Identifier: NCT00390377     History of Changes
Other Study ID Numbers: FT240-2006
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: October 19, 2006
Last Verified: October 2006

Keywords provided by Fermiscan Ltd:
x-ray diffraction
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases