Status:
UNKNOWN
Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older
Lead Sponsor:
POC Medical Systems, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast canc...
Detailed Description
2400 subjects will be screened for breast cancer in seven enrolling sites across the country to ensure diverse ethnicity. "Positive" subjects should be confirmed breast cancer positive by Mammography...
Eligibility Criteria
Inclusion
- Ability to give informed consent. Written informed consent by the patient/patient's legally acceptable representative (LAR) for donating blood sample
- Documented absence of cancer (other than Breast Cancer)
- Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any stage
- Blood sample taken before any treatment for Breast Cancer was administered to the subject.
Exclusion
- Other malignancy besides breast cancer in the 5 years prior to obtaining the sample.
- Therapies for breast cancer that have been administered within 1 year of obtaining the sample
- Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating in the study.
Key Trial Info
Start Date :
June 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
2458 Patients enrolled
Trial Details
Trial ID
NCT03243877
Start Date
June 17 2017
End Date
August 31 2018
Last Update
April 11 2018
Active Locations (7)
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1
KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals
Hyderabad, Andhra Pradesh, India, 500003
2
Indo American Cancer Hospital and Research Institute
Hyderabad, Andhra Pradesh, India, 500034
3
HCG MULTI Specialty Hospital HCG Cancer Center
Ahmedabad, Gujarat, India, 380006
4
Manipal Hospital
Bangalore, Karnataka, India, 560017