Health Condition 1: null- Breast Cancer Suspects
Conditions
Interventions
Intervention1: Pandora CDx MammoAlert TM: POC Medical Systems has developed the Mammo Alert system using the Pandora CDx Platform which will allow for rapid low cost portable screening of millions of
Sponsors
POC Medical Systems Inc
Eligibility
Inclusion criteria
Inclusion criteria: a) Sex female. b) Age between 18 and above. c) Ability to give informed consent. Written informed consent by the patient/patientâ??s legally acceptable representative (LAR) for donating blood sample. d) Documented absence of cancer, other than breast cancer
Exclusion criteria
Exclusion criteria: a) Other malignancy besides breast cancer in the 5 years prior to obtaining the sample. b) Therapies for breast cancer that have been administered in less than 1 year prior to obtaining the sample. c) Any condition (including psychiatric), which in the Investigatorâ??s opinion, places the patient at undue risk by participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiency of the Pandora CDx MammoAlertTM, a novel Breast Cancer Panel to screen subjects who are confirmed for breast cancer (Mix population of Stage I-IV of either IDC or ILC or both) by Mammography and/or Biopsy will be confirmedTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The Sensitivity and Accuracy of Pandora CDx MammoAlertTM, a Breast Cancer Panel will be knownTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Smita Singhania
Poc Medical Systems Inc
Outcome results
None listed