Clinical trial NCT00419900: Use of Hair to Diagnose the Presence of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
diagnosis
x-ray diffraction
synchrotron
hair
Lead sponsor: Fermiscan Ltd
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Primary outcomes:
measure: Accuracy (sensitivity and specificity) of the breast cancer test based on detection of an abnormal pattern of hair x-ray diffraction compared to the gold standard of mammography plus biopsy where indicated
Secondary outcomes:
measure: The prevalence of a positive hair x-ray diffraction pattern and a negative mammogram; and the prevalence of a negative hair x-ray diffraction pattern and a positive mammogram;
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Bankstown Diagnostic Imaging Centre
state: New South Wales
city: Sydney
country: Australia
facility: Campbelltown Ultrascan Radiology
state: New South Wales
city: Sydney
country: Australia
facility: Diagnostic Imaging Centre, St George Private Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Ultrascan Radiology
state: New South Wales
city: Sydney
country: Australia
facility: Penrith Imaging
state: New South Wales
Study officials:
affiliation: Radiation Oncology Associates, Sydney, Australia
name: Phillip Yuile, MBBS, FRACR
role: PRINCIPAL_INVESTIGATOR
References:
citation: James VJ. A place for fiber diffraction in the detection of breast cancer? Cancer Detect Prev. 2006;30(3):233-8. doi: 10.1016/j.cdp.2006.04.001. Epub 2006 Jul 28.
citation: James V, Corino G, Robertson T, Dutton N, Halas D, Boyd A, Bentel J, Papadimitriou J. Early diagnosis of breast cancer by hair diffraction. Int J Cancer. 2005 May 10;114(6):969-72. doi: 10.1002/ijc.20824.
citation: James V. False-positive results in studies of changes in fiber diffraction of hair from patients with breast cancer may not be false. J Natl Cancer Inst. 2003 Jan 15;95(2):170-1. doi: 10.1093/jnci/95.2.170. No abstract available.
citation: Meyer P, James VJ. Experimental confirmation of a distinctive diffraction pattern in hair from women with breast cancer. J Natl Cancer Inst. 2001 Jun 6;93(11):873-5. doi: 10.1093/jnci/93.11.873. No abstract available.
citation: James V, Kearsley J, Irving T, Amemiya Y, Cookson D. Using hair to screen for breast cancer. Nature. 1999 Mar 4;398(6722):33-4. doi: 10.1038/17949. No abstract available.