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Trial Title:
Use of Hair to Diagnose Breast Cancer
NCT ID:
NCT00419679
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
hair
fibre
synchrotron
x-ray diffraction
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
Single
Intervention:
Intervention type:
Procedure
Intervention name:
x-ray diffraction of human hair
Summary:
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.
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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Mater Hospital
Address:
City:
Sydney
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Phillip Yuile, MBBS (Hons), FRNZCR
Phone:
+61299292600
Email:
yuilep@optushome.com.au
Start date:
December 2006
Lead sponsor:
Agency:
Fermiscan Ltd
Agency class:
Industry
Source:
Fermiscan Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00419679
