Use of Hair to Diagnose Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Fermiscan Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fermiscan Ltd
ClinicalTrials.gov Identifier:
NCT00419679
First received: January 7, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Procedure: x-ray diffraction of human hair
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Fermiscan Ltd:

Primary Outcome Measures:
  • 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:
  • The prevalence of a positive x-ray diffraction hair test and a negative mammogram, and of a negative hair test and a positive mammogram

Estimated Enrollment: 3600
Study Start Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00419679

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

Locations
Australia, New South Wales
The Mater Hospital Recruiting
Sydney, New South Wales, Australia, 2065
Contact: Phillip Yuile, MBBS (Hons), FRNZCR    +61299292600    yuilep@optushome.com.au   
Sponsors and Collaborators
Fermiscan Ltd
Investigators
Principal Investigator: Phillip Yuile, MBBS (Hons), FRNZCR The Mater Hospital, Sydney