Use of Hair to Diagnose Breast Cancer

NCT ID: NCT00390377

Last Updated: 2006-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

x-ray diffraction hair breast cancer synchrotron

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cutting scalp hair

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 hair

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fermiscan Ltd

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ronald Shnier, MBBS, FRACR

Role: PRINCIPAL_INVESTIGATOR

Symbion Health

Gary Corino, BSc

Role: STUDY_DIRECTOR

Fermiscan Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St George Private Hospital

Sydney, New South Wales, Australia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Peter W French, BSc, MSc, PhD

Role: CONTACT

Phone: +61292454460

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15645416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10078527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11390537 (View on PubMed)

James 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.

Reference Type BACKGROUND
PMID: 12587913 (View on PubMed)

Kimura 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.

Reference Type BACKGROUND
PMID: 1289498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12529353 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FT240-2006

Identifier Type: -

Identifier Source: org_study_id