Breast CancerPhase 2NCT00390377
Use of Hair to Diagnose Breast Cancer
A Phase 2 study testing Cutting scalp hair in people with Breast Cancer, run by Fermiscan Ltd at 1 site in Australia.
Trial summary
This study aims to perform x-ray diffraction analysis of blinded hair samples from women with a documented health status, to validate the previous findings of James et al who described that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects from those of diseased subjects… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cutting scalp hair
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2006to not given
- Phase
- Phase 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
- Adult, Older adult
Who may be able to join
- Adult women (aged >20) who are undergoing mammography, and
- Who are willing and able to provide informed consent; and
- Who have usable scalp hair
Who cannot join
- 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
St George Private Hospital
Sydney, New South Wales, 2217
Ronald Shnier, MBBS, FRACR
About this study
Official title: A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.
This study aims to perform x-ray diffraction analysis of blinded hair samples from women with a documented health status, to validate the previous findings of James et al who described that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects from those of diseased subjects, specifically those suffering from breast cancer.
The primary hypothesis is that x-ray diffraction of hair can be used to distinguish hair from patients with confirmed breast cancer from subjects without detectable breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Cutting scalp hair
- Keywords
- x-ray diffraction, hair, breast cancer, synchrotron
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutting scalp hairProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Fermiscan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ronald Shnier, MBBS, FRACR, Principal investigator, Symbion HealthGary Corino, BSc, Study director, Fermiscan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390377
- Sponsor's protocol ID
- FT240-2006
- Status last verified
- Oct 2006
- First submitted
- 17 Oct 2006
- Last updated
- 19 Oct 2006
- Results posted
- No
Publications
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.
PubMed 15645416James 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 10078527Meyer 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 VJ. The traps and pitfalls inherent in the correlation of changes in the fibre diffraction pattern of hair with breast cancer. Phys Med Biol. 2003 Jan 21;48(2):L5-9; discussion L11-3. doi: 10.1088/0031-9155/48/2/101.
PubMed 12587913Kimura M, Tanaka N, Kimura Y, Miyake K, Kitaura T, Fukuchi H. Pharmacokinetic interaction of zonisamide in rats. Effect of other antiepileptics on zonisamide. J Pharmacobiodyn. 1992 Nov;15(11):631-9. doi: 10.1248/bpb1978.15.631.
PubMed 1289498James 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 12529353
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate a Test for the Diagnosis of Breast Cancer Using X-Ray Diffraction of Hair Fibres.
- ClinicalTrials.gov ID
- NCT00390377
- Acronym / sponsor ID
- FT240-2006
- Conditions
- Breast Cancer
- Keywords
- x-ray diffraction, hair, breast cancer, synchrotron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants
- Lead sponsor
- Fermiscan LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 19 Oct 2006 (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.
This study aims to perform x-ray diffraction analysis of blinded hair samples from women with a documented health status, to validate the previous findings of James et al who described that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects from those of diseased subjects, specifically those suffering from breast cancer.
The primary hypothesis is that x-ray diffraction of hair can be used to distinguish hair from patients with confirmed breast cancer from subjects without detectable breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult women (aged >20) who are undergoing mammography, and
- Who are willing and able to provide informed consent; and
- Who have usable scalp hair
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Cutting scalp hair | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2006.
- 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 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.
- 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 12587913James VJ. The traps and pitfalls inherent in the correlation of changes in the fibre diffraction pattern of hair with breast cancer. Phys Med Biol. 2003 Jan 21;48(2):L5-9; discussion L11-3. doi: 10.1088/0031-9155/48/2/101.
- Background: PubMed 1289498Kimura M, Tanaka N, Kimura Y, Miyake K, Kitaura T, Fukuchi H. Pharmacokinetic interaction of zonisamide in rats. Effect of other antiepileptics on zonisamide. J Pharmacobiodyn. 1992 Nov;15(11):631-9. doi: 10.1248/bpb1978.15.631.
- 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.
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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.
Ronald Shnier, MBBS, FRACR principal investigator
Symbion Health
Gary Corino, BSc study director
Fermiscan Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cutting scalp hair in people with Breast Cancer, 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 1 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 19 Oct 2006. 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 phase mean?
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 W French, BSc, MSc, PhD (+61292454460, pfrench@fermiscan.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00390377, which also lists 6 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 19 Oct 2006.