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Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test

NCT02066025 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1425

Last updated 2014-02-19

No results posted yet for this study

Summary

Octava has two versions, each with a different intend of use.

OctavaPink is a qualitative in vitro diagnostic test service, performed by authorized clinical laboratories. The product is used for two following indications:

* Intend of Use #1: OctavaPink is indicated for women above 18 years old, who performed mammography and were determined negative for breast cancer. Being moderately sensitive (\>55% sensitivity) the test is able to detect 55% of mammography false negatives. In addition, being highly specific (\>95% specificity) it supplies additional evidence for true mammography negative result which will reduce examinees anxiety of being misdiagnosed as a result of high false negative mammography rate (10-30%)
* Intend of Use #2: OctavaPink is indicated for women above 18 years old, who performed biopsy after positive mammography and the biopsy result was negative. Being moderately sensitive (\>55% sensitivity) the test is able to detect 55% of biopsy false negatives. In addition being highly specific (\>95% specificity) it supplies an additional evidence for true biopsy negative result which reduces examinees anxiety of being misdiagnosed.

OctavBlue is a qualitative in vitro diagnostic test service, performed by EventusDx authorized laboratories. Intend of use of OctavBlue is the following:

• OctavBlue is indicated for women above 18 years old, who performed mammography and received doubtful results. Being highly sensitive (\>95% sensitivity) the test can help to reveal 95% of positive cases; and being moderately specific (\>55% specificity) - about half of negative cases. The test is not intended to be used as a standalone diagnostic technique but to supply additional information to a physician and help deciding about the further course of diagnosis.

Conditions

Sponsors & Collaborators

  • Eventus Diagnostics Ltd

    lead INDUSTRY

Principal Investigators

  • Galit Yahalom, Ph.D · Eventus Dx

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-03-31
Completion
2018-03-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02066025 on ClinicalTrials.gov