Breast NeoplasmsPhase 1/2NCT00419679
Use of Hair to Diagnose Breast Cancer
A Phase 1/2 study testing x-ray diffraction of human hair in people with Breast Neoplasms, run by Fermiscan Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- x-ray diffraction of human hair
- Type of treatment
- Surgery or procedure
- How many people
- 3,600 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2006to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
The Mater Hospital
Sydney, New South Wales, 2065
Phillip Yuile, MBBS (Hons), FRNZCR, +61299292600, yuilep@optushome.com.au
About this study
Official 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.
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- x-ray diffraction of human hair
- Keywords
- breast cancer, hair, fibre, synchrotron, x-ray diffraction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-ray diffraction of human hairProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (1)
The prevalence of a positive x-ray diffraction hair test and a negative mammogram, and of a negative hair test and a positive mammogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 3,600 participants
Sponsor and investigators
- Lead sponsor
- Fermiscan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Phillip Yuile, MBBS (Hons), FRNZCR, Principal investigator, The Mater Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419679
- Sponsor's protocol ID
- FT3.6k-2006
- Status last verified
- Jan 2007
- First submitted
- 7 Jan 2007
- Last updated
- 9 Jan 2007
- Results posted
- No
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.
PubMed 16876335James 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.
PubMed 15645416James 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.
PubMed 12529353Meyer 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.
PubMed 11390537James 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.
PubMed 10078527
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00419679
- Acronym / sponsor ID
- FT3.6k-2006
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, hair, fibre, synchrotron, x-ray diffraction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,600 participants
- Lead sponsor
- Fermiscan LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- First posted
- 9 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| x-ray diffraction of human hair | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
The prevalence of a positive x-ray diffraction hair test and a negative mammogram, and of a negative hair test and a positive mammogram
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2007.
- Background: PubMed 16876335James 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.
- Background: PubMed 15645416James 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.
- Background: PubMed 12529353James 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.
- Background: PubMed 11390537Meyer 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.
- Background: PubMed 10078527James 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Yuile, MBBS (Hons), FRNZCR principal investigator
The Mater Hospital, Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing x-ray diffraction of human hair in people with Breast Neoplasms, run by Fermiscan Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter French, BSc, MSc, PhD (+61292454460, pfrench@fermiscan.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00419679, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2007.