NCT03243877

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

July 25, 2017

Last Update Submit

April 10, 2018

Conditions

Breast Cancer

Keywords

ScreeningMammography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Predictive values & likelihood ratios

    Predictive values & likelihood ratios will be calculated at 4-months

Other Outcomes (2)

  • Accuracy of test

    Accuracy of test will be calculated at 4-months

  • Reproducibility

    Reproducibility will be calculated at 4-months

Study Arms (2)

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

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

Interventions

MammoAlert Screening TestOTHER

Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.

Breast Cancer NegativeBreast Cancer Positive

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen only
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The present study targets women of at least 18 years old

You may qualify if:

  • Ability to give informed consent. Written informed consent by the patient/patient's legally acceptable representative (LAR) for donating blood sample
  • Documented absence of cancer (other than Breast Cancer)
  • Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any stage
  • Blood sample taken before any treatment for Breast Cancer was administered to the subject.

You may not qualify if:

  • Other malignancy besides breast cancer in the 5 years prior to obtaining the sample.
  • Therapies for breast cancer that have been administered within 1 year of obtaining the sample
  • Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals

Hyderabad, Andhra Pradesh, 500003, India

Location

Indo American Cancer Hospital and Research Institute

Hyderabad, Andhra Pradesh, 500034, India

Location

HCG MULTI Specialty Hospital HCG Cancer Center

Ahmedabad, Gujarat, 380006, India

Location

Manipal Hospital

Bangalore, Karnataka, 560017, India

Location

Amrita Institute of Medical Sciences and Research Centre

Kochi, Kerala, India

Location

Tata Medical Center

Kolkata, West Bengal, 700160, India

Location

Maulana Azad Medical College University of Delhi & Associated Lok Nayak Hospital

New Delhi, 110002, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Raghu Ram Pillarisetti, MD

    KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 9, 2017

Study Start

June 17, 2017

Primary Completion

November 26, 2017

Study Completion

August 31, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(7)