Clinical trial NCT03243877: Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older
Official title: Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity & Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Screening
Mammography
Lead sponsor: POC Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-09
Enrollment: 2458
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The present study targets women of at least 18 years old

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 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.

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 and/or biopsy. Breast cancer positive samples will be compared to the control group of samples obtained from women attending clinics for non-cancerous related pathology.

Both Positive and Negative Predictive Values will be evaluated to determine accuracy and sensitivity of the screening test.

Subjects whose known cancer positive or negative status do not match the test report will be followed up as appropriate, on case by case basis to identify false positive and false negative results.

Eligibility criteria: 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.

Primary outcomes:
measure: Screening performance (i.e., sensitivity and specificity)
timeFrame: Screening performance will be calculated at 4-months
Secondary outcomes:
measure: Predictive values & likelihood ratios
timeFrame: Predictive values & likelihood ratios will be calculated at 4-months
Other outcomes:
measure: Accuracy of test
timeFrame: Accuracy of test will be calculated at 4-months
measure: Reproducibility
timeFrame: Reproducibility will be calculated at 4-months
Locations:
city: Hyderabad
country: India
facility: KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Indo American Cancer Hospital and Research Institute
state: Andhra Pradesh
city: Ahmadabad
country: India
facility: HCG MULTI Specialty Hospital HCG Cancer Center
state: Gujarat
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences and Research Centre
state: Kerala
city: Kolkata
country: India
facility: Tata Medical Center
state: WEST Bengal
city: New Delhi
country: India
facility: Maulana Azad Medical College University of Delhi & Associated Lok Nayak Hospital
Study officials:
affiliation: KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals
name: Raghu Ram Pillarisetti, MD
role: PRINCIPAL_INVESTIGATOR
References: