Clinical trial · Interventional
Use of Hair to Diagnose Breast Cancer
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| x-ray diffraction of human hair | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
Secondary outcomes (1)
- measure
- The prevalence of a positive x-ray diffraction hair test and a negative mammogram, and of a negative hair test and a positive mammogram
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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 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.
References
Publications (5)
- BACKGROUNDJames 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. PMID 16876335
- BACKGROUNDJames 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. PMID 15645416
- BACKGROUNDJames 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. PMID 12529353
- BACKGROUNDMeyer 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. PMID 11390537
- BACKGROUNDJames 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. PMID 10078527