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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00419679




Registration number
NCT00419679
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 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
Sex
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
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
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/ct2/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. 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 (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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00419679