Clinical trial · Interventional
Use of Hair to Diagnose the Presence of Breast Cancer
- 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)
Using synchrotron X-ray diffraction, it has been reported that a hair from an individual with breast cancer exhibits a difference in its molecular structure compared to that of an individual without breast cancer. This difference is visible in the X-ray diffraction pattern as a ring superimposed on the pattern for normal hair. The hypothesis of this study is that synchrotron x-ray diffraction can be used to differentiate hairs from women with medically diagnosed breast cancer from women not known to have the disease. To test this hypothesis, hair from 2000 women attending radiology clinics for mammography will be collected, analysed by x-ray diffraction and then analysed using Fermiscan proprietary image analysis software. The mammogram status of the subjects will be blinded from the diffraction analysts. Results will then be compared with mammography results to allow a direct comparison between the Fermiscan test and mammography in terms of specificity and sensitivity.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnosis of breast cancer by x-ray diffraction of hair | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Accuracy (sensitivity and specificity) of the breast cancer test based on detection of an abnormal pattern of hair x-ray diffraction compared to the gold standard of mammography plus biopsy where indicated
Secondary outcomes (1)
- measure
- The prevalence of a positive hair x-ray diffraction pattern and a negative mammogram; and the prevalence of a negative hair x-ray diffraction pattern 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, 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