Viewing Study NCT00419900



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Last Modification Date: 2024-10-26 @ 9:30 AM
Study NCT ID: NCT00419900
Status: UNKNOWN
Last Update Posted: 2007-01-09
First Post: 2007-01-07

Brief Title: Use of Hair to Diagnose the Presence of Breast Cancer
Sponsor: Fermiscan Ltd
Organization: Fermiscan Ltd

Study Overview

Official Title: None
Status: UNKNOWN
Status Verified Date: 2007-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None