Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00419900




Registration number
NCT00419900
Ethics application status
Date submitted
7/01/2007
Date registered
9/01/2007
Date last updated
9/01/2007

Titles & IDs
Public title
Use of Hair to Diagnose the Presence of Breast Cancer
Scientific title
Secondary ID [1] 0 0
FER2k
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - diagnosis of breast cancer by x-ray diffraction of hair

Treatment: Surgery: diagnosis of breast cancer by x-ray diffraction of hair
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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;
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
20 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Screening
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Bankstown Diagnostic Imaging Centre - Sydney
Recruitment hospital [2] 0 0
Campbelltown Ultrascan Radiology - Sydney
Recruitment hospital [3] 0 0
Diagnostic Imaging Centre, St George Private Hospital - Sydney
Recruitment hospital [4] 0 0
Liverpool Ultrascan Radiology - Sydney
Recruitment hospital [5] 0 0
Penrith Imaging - Sydney
Recruitment postcode(s) [1] 0 0
2200 - Sydney
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fermiscan Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00419900
Trial related presentations / publications
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.
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.
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. Erratum In: J Natl Cancer Inst. 2003 Feb 19;95(4):334.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Phillip Yuile, MBBS, FRACR
Address 0 0
Radiation Oncology Associates, Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter W French, BSc, MSc, PhD
Address 0 0
Country 0 0
Phone 0 0
+61292454460
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00419900