NCT00419679

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,600

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
Last Updated

January 9, 2007

Status Verified

January 1, 2007

First QC Date

January 7, 2007

Last Update Submit

January 7, 2007

Conditions

Breast Neoplasms

Keywords

breast cancerhairfibresynchrotronx-ray diffraction

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

x-ray diffraction of human hairPROCEDURE

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mater Hospital

Sydney, New South Wales, 2065, Australia

RECRUITING

Related Publications (5)

  • 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.

    PMID: 16876335BACKGROUND

  • 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.

    PMID: 15645416BACKGROUND

  • 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.

    PMID: 12529353BACKGROUND

  • 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.

    PMID: 11390537BACKGROUND

  • 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.

    PMID: 10078527BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Phillip Yuile, MBBS (Hons), FRNZCR

    The Mater Hospital, Sydney

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter French, BSc, MSc, PhD

CONTACT

+61292454460pfrench@fermiscan.com.au

Gary Corino, BSc

CONTACT

+61292454460gcorino@fermiscan.com.au

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2007

First Posted

January 9, 2007

Study Start

December 1, 2006

Last Updated

January 9, 2007

Record last verified: 2007-01

Locations

AU(1)