Use of Hair to Diagnose Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Fermiscan Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fermiscan Ltd
ClinicalTrials.gov Identifier:
NCT00390377
First received: October 17, 2006
Last updated: October 18, 2006
Last verified: October 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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

Ages Eligible for Study:   20 Years and older
Genders 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
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: 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
Study First Received: October 17, 2006
Last Updated: October 18, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on September 22, 2014