Use of Hair to Diagnose Breast Cancer

January 7, 2007 updated by: Fermiscan Ltd

A Prospective Blinded Study to Evaluate and Characterise an Assay for the Diagnosis of Breast Cancer Using Synchrotron-Derived X-Ray Diffraction of Hair Fibres.

Study FT3.6k-2006 is a single centre (the Mater Hospital, Sydney), blinded trial of a diagnostic test for breast cancer, with outcomes compared to the gold standard of screening mammogram followed by biopsy where required. This study aims to perform X-ray diffraction analysis of coded hair samples from women with a documented breast health status, to validate the findings of James et al (Nature 398: 33-4, 1999; Int J Cancer 114: 969-72, 2005) who showed that the presence of breast cancer could be detected using synchrotron-derived x-ray diffraction of human hair (scalp or pubic). The aim is also to characterise the sensitivity and specificity of the hair test in detecting breast cancer in a screening setting, and to determine the significance of a positive hair test and a negative mammogram.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The test has the potential to improve the diagnostic (and consequently therapeutic) paradigm for breast cancer.

Women attending a radiology clinic in the Mater Hospital, Sydney, for a mammogram will be invited to participate in the study. A few hairs will be cut from their head or pubic region, put into a coded container and sent to the sponsor for analysis by synchrotron-x-ray diffraction. Although an imperfect standard for a variety of reasons, mammography is the standard screening assay, and confirmation of the pathology of the lesions found by mammography is carried out by biopsy. This will be the standard to which the hair test results will be compared. A negative mammogram will confirm a negative hair test, but a negative mammogram combined with a positive hair diffraction test will need a different approach. In the event of a positive hair test and a negative second read of the mammogram, the patient will be contacted by the referring practitioner. Patients in this category will be offered a breast MRI. A negative breast MRI under these circumstances will be classified as a true negative.

Study Type

Interventional

Enrollment

3600

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2065
        • Recruiting
        • The Mater Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult women (aged >20) who are undergoing mammography at the Mater Hospital, Sydney, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome is the determination of the accuracy (sensitivity and specificity) of the x-ray diffraction test for breast cancer using hair. Sensitivity is defined as the proportion of all positive Fermiscan tests that are true positives.

Secondary Outcome Measures

Outcome Measure
The prevalence of a positive x-ray diffraction hair test and a negative mammogram, and of a negative hair test and a positive mammogram

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fermiscan Ltd

Investigators

  • Principal Investigator: Phillip Yuile, MBBS (Hons), FRNZCR, The Mater Hospital, Sydney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 7, 2007

First Submitted That Met QC Criteria

January 7, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

January 9, 2007

Last Update Submitted That Met QC Criteria

January 7, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT3.6k-2006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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