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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02066025
• Other study ID #: OctavaBreast_1
• Status: Not yet recruiting
• Phase: N/A
• First received: February 9, 2014
• Last updated: February 17, 2014
• Start date: March 2014
• Est. completion date: March 2018

Study information

• Verified date: February 2014
• Source: Eventus Diagnostics Ltd
• Contact: Galit Yahalom, Ph.D
• Phone: +972546922422
• Email: galit[@]eventusdx.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1425
• Est. completion date: March 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Israel	"Carmel" Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Eventus Diagnostics Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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 Improve — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants in each of the clinicaly defined groups (0,1 and 2).		3 years	No