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.

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: MammoAlert Screening Test

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.

• Study Type: Observational
• Enrollment (Actual): 2458

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110002
    • Maulana Azad Medical College University of Delhi & Associated Lok Nayak Hospital
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500003
      • KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals
    • Hyderabad, Andhra Pradesh, India, 500034
      • Indo American Cancer Hospital and Research Institute
  • Gujarat
    • Ahmadabad, Gujarat, India, 380006
      • HCG MULTI Specialty Hospital HCG Cancer Center
  • Karnataka
    • Bangalore, Karnataka, India, 560017
      • Manipal Hospital
  • Kerala
    • Kochi, Kerala, India
      • Amrita Institute of Medical Sciences and Research Centre
  • WEST Bengal
    • Kolkata, WEST Bengal, India, 700160
      • Tata Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The present study targets women of at least 18 years old

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast Cancer Positive; 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.	Other: MammoAlert Screening Test; Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.
Breast Cancer Negative; 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.	Other: MammoAlert Screening Test; Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening performance (i.e., sensitivity and specificity)	Screening performance: comprises the sensitivity and specificity of MammoAlert™. It represents the performance of the diagnostic test and is therefore independent of the prevalence of the disease in the studied sample of patients.	Screening performance will be calculated at 4-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive values & likelihood ratios	Positive predictive value: the probability that a subject has the disease given that the test result is positive will be estimated by: TP/(TP+FP). Negative predictive value: the probability that a subject does not have the disease given that the result of the test is negative will be estimated by TN/(TN+FN). Likelihood ratio (LR): the likelihood that a given test result would be expected in a patient with the target disorder compared to the likelihood that that same result would be expected in a patient without the target disorder.	Predictive values & likelihood ratios will be calculated at 4-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of test	The probability that the test result reflects the true disease state will be estimated as the proportion of cases for which the test result is correct: (TP+TN)/(TP+FP+TN+FN).	Accuracy of test will be calculated at 4-months
Reproducibility	The ability of MammoAlert™ to reveal the same result when repeatedly performed on the same sample, assessed repeatedly by the same reader	Reproducibility will be calculated at 4-months

Collaborators and Investigators

• Sponsor: POC Medical Systems, Inc.
• Investigators: Principal Investigator: Raghu Ram Pillarisetti, MD, KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2017
• Primary Completion (ACTUAL): November 26, 2017
• Study Completion (ANTICIPATED): August 31, 2018

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (ACTUAL): August 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Screening; Mammography
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: POC-BC-0217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No