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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00419679




Trial ID
NCT00419679
Ethics application status
Date submitted
7/01/2007
Date registered
7/01/2007
Date last updated
7/01/2007

Titles & IDs
Public title
Use of Hair to Diagnose Breast Cancer
Scientific 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.
Secondary ID [1] 0 0
FT3.6k-2006
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Treatment: Surgery: x-ray diffraction of human hair


Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The prevalence of a positive x-ray diffraction hair test and a negative mammogram, and of a negative hair test and a positive mammogram
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
20 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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
Diagnosis
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
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
The Mater Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2065 - Sydney

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00419679
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. 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.
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. 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Phillip Yuile, MBBS (Hons), FRNZCR
Address 0 0
The Mater Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter French, BSc, MSc, PhD
Address 0 0
Country 0 0
Phone 0 0
+61292454460
Fax 0 0
Email 0 0
pfrench@fermiscan.com.au
Contact person for scientific queries