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Use of Hair to Diagnose the Presence of Breast Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase IScreeningActive20 and overPharmaceutical / IndustryFER2k
NCT00419900

Trial Description

Summary

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Fermiscan Limited

Phillip Yuile, MBBS, FRACRPrincipal Investigator

Peter W French, BSc, MSc, PhDPh: +61292454460
  Email: pfrench@fermiscan.com.au

Trial Sites

Australia
New South Wales
  Sydney
 Bankstown - Lidcombe Hospital
 Cancer Therapy Centre at Campbelltown Hospital
 Cancer Therapy Centre at Liverpool Hospital
 Penrith Imaging
 St. George Private Hospital

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00419900
Information obtained from ClinicalTrials.gov on December 14, 2011

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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