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Use of Hair to Diagnose Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by Fermiscan Ltd.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00390377
First Posted: October 19, 2006
Last Update Posted: October 19, 2006
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.
Information provided by:
Fermiscan Ltd
  Purpose

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 Intervention Phase
Breast Cancer Procedure: Cutting scalp hair Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Fermiscan Ltd:

Estimated Enrollment: 240
Study Start Date: October 2006
  Eligibility

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
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 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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00390377


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

Locations
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
Investigators
Principal Investigator: Ronald Shnier, MBBS, FRACR Symbion Health
Study Director: Gary Corino, BSc Fermiscan Ltd
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00390377     History of Changes
Other Study ID Numbers: FT240-2006
First Submitted: October 17, 2006
First Posted: October 19, 2006
Last Update Posted: October 19, 2006
Last Verified: October 2006

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

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