To hear about similar clinical trials, please enter your email below

Trial Title: Use of Hair to Diagnose the Presence of Breast Cancer

NCT ID: NCT00419900

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
breast cancer
diagnosis
x-ray diffraction
synchrotron
hair

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Screening

Masking: Single

Intervention:

Intervention type: Procedure
Intervention name: diagnosis of breast cancer by x-ray diffraction of hair

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.

Criteria for 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 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.

Gender: Female

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Bankstown Diagnostic Imaging Centre

Address:
City: Sydney
Zip: 2200
Country: Australia

Status: Recruiting

Facility:
Name: Campbelltown Ultrascan Radiology

Address:
City: Sydney
Country: Australia

Status: Recruiting

Facility:
Name: Diagnostic Imaging Centre, St George Private Hospital

Address:
City: Sydney
Country: Australia

Status: Recruiting

Facility:
Name: Liverpool Ultrascan Radiology

Address:
City: Sydney
Country: Australia

Status: Recruiting

Facility:
Name: Penrith Imaging

Address:
City: Sydney
Country: Australia

Status: Recruiting

Start date: December 2006

Lead sponsor:
Agency: Fermiscan Ltd
Agency class: Industry

Source: Fermiscan Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00419900

Login to your account

Did you forget your password?