Clinical trial · Observational
Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older
Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity & Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. The present study aims to determine the Sensitivity and Specificity of the test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MammoAlert Screening Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Breast Cancer Positive
- description
- A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were positive. MammoAlert Screening Test will be performed on plasma obtained from the blood sample.
- interventionNames
- Other: MammoAlert Screening Test
- label
- Breast Cancer Negative
- description
- A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were negative. MammoAlert Screening Test will be performed on plasma obtained from the blood sample.
- interventionNames
- Other: MammoAlert Screening Test
Primary outcomes (1)
- measure
- Screening performance (i.e., sensitivity and specificity)
- timeFrame
- Screening performance will be calculated at 4-months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to give informed consent. Written informed consent by the patient/patient's legally acceptable representative (LAR) for donating blood sample 2. Documented absence of cancer (other than Breast Cancer) 3. Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any stage 4. Blood sample taken before any treatment for Breast Cancer was administered to the subject. Exclusion Criteria: 1. Other malignancy besides breast cancer in the 5 years prior to obtaining the sample. 2. Therapies for breast cancer that have been administered within 1 year of obtaining the sample 3. Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating in the study.
References
Publications (0)
Data not yet available