Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03243877
• Other study ID #: POC-BC-0217
• Status: Active, not recruiting
• First received: July 25, 2017
• Last updated: April 10, 2018
• Start date: June 17, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: April 2018
• Source: POC Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2458
• Est. completion date: August 31, 2018
• Est. primary completion date: November 26, 2017
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
India	HCG MULTI Specialty Hospital HCG Cancer Center	Ahmadabad	Gujarat
India	Manipal Hospital	Bangalore	Karnataka
India	Indo American Cancer Hospital and Research Institute	Hyderabad	Andhra Pradesh
India	KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals	Hyderabad	Andhra Pradesh
India	Amrita Institute of Medical Sciences and Research Centre	Kochi	Kerala
India	Tata Medical Center	Kolkata	WEST Bengal
India	Maulana Azad Medical College University of Delhi & Associated Lok Nayak Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
POC Medical Systems, Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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