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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.


Phase 1/Phase 2
20 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

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.

Principal Investigator

Phillip Yuile, MBBS (Hons), FRNZCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Mater Hospital, Sydney

Authority:

Australia: National Health and Medical Research Council

Study ID:

FT3.6k-2006

NCT ID:

NCT00419679

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • breast cancer
  • hair
  • fibre
  • synchrotron
  • x-ray diffraction
  • Breast Neoplasms
  • Neoplasms

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