Use of Hair to Diagnose Breast Cancer | NCT00390377

Studies
Use of Hair to Diagnose Breast Cancer

NCT00390377

Sponsor

Fermiscan Ltd

Status

Unknown status

Last Update Posted

Oct 19, 2006Estimated

Enrollment

240

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Cutting scalp hair

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 17, 2006

First Submission Date that Met QC Criteria

Oct 18, 2006

First Posted Date

Oct 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2006

Last Update Posted Date

Oct 19, 2006Estimated

Description Module

Brief 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, 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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240

Name	Type	Description	Arm Group Labels	Other Names
Cutting scalp hair	Procedure

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter W French, BSc, MSc, PhD	Contact	+61292454460		pfrench@fermiscan.com.au

Overall Officials

Name	Affiliation	Role
Ronald Shnier, MBBS, FRACR	Symbion Health	Principal Investigator
Gary Corino, BSc	Fermiscan Ltd	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St George Private Hospital	Recruiting	Sydney	New South Wales	2217	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15645416	Background	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.
10078527	Background	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases