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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer

Detailed Description

The primary objectives - To improve the specifications of the OctavaPink test and the OctavaBlue test. The current specifications being

1. For the OctavaPink - 95% specificity and 50% sensitivity.
2. For the OctavaBlue - 50% specificity and 95% sensitivity.

The study will be considered as successful in any of the below options -

1. If the new antigens incorporated in the OctavaPink chip will maintain specificity of at least 95% and increase the sensitivity to at least 85%.
2. If the new antigens incorporated in the OctavaBlue chip will maintain sensitivity of at least 95% and increase the specificity to at least 85%.

• Study Type: Observational
• Enrollment (Anticipated): 1425

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 34362
    • "Carmel" Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The target population will be any women with a mammography result (positive or negative).

Women with negative mammography will be tested with the OctavaPink version to provide additional information to the doctors following a negative mammography.

Women with a positive mammography will be tested with OctavaBlue version to provide additional information to a physician.

Description

Inclusion Criteria:

• Female subjects 18 years or over.
• Subjects following a mammography test.
• Subject with pathological evaluation after mammography with BIRADS 3-4-5-6.

Exclusion Criteria:

• Female Subjects less than 18 years of age
• Previous or concurrent malignancies
• Autoimmune disorders diagnosed subjects
• Hematological malignancies
• Subjects under active chemotherapy treatment or chemotherapy in the past 6 months
• Steroid treatment in the past 3 months
• Subject undergoing immunosuppressive treatments
• Subject with verified breast cancer other than invasive ductal or invasive lobular as verified by biopsy/cytology

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
group_0; Women with negative mammography (BIRADS 1-2), as negative controls.
group_1; Women with positive biopsy for (ID, IL, DCIS) as patients.
group_2; Women with positive mammography (BIRADS 3-4-5-6), and a negative biopsy diagnosis for breast cancer (ID, IL, DCIS) will be enrolled as benign (ADH, ALH, LCIS, fibroadenoma, fibrocystic changes (including sclerosing adenosis), Benign papillaoma, normal breast) as benigns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants in each of the clinicaly defined groups (0,1 and 2).	3 years

Collaborators and Investigators

• Sponsor: Eventus Diagnostics Ltd
• Investigators: Study Director: Galit Yahalom, Ph.D, Eventus Dx

Publications and helpful links

General Publications

• Yahalom G, Weiss D, Novikov I, Bevers TB, Radvanyi LG, Liu M, Piura B, Iacobelli S, Sandri MT, Cassano E, Allweis TM, Bitterman A, Engelman P, Vence LM, Rosenberg MM. An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis. Biomark Cancer. 2013 Nov 19;5:71-80. doi: 10.4137/BIC.S13236. eCollection 2013.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: February 9, 2014
• First Submitted That Met QC Criteria: February 17, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Estimate): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 17, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: breast cancer; cancer associated auto antibodies; breast cancer blood test
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OctavaBreast_1