Blood Test for Breast Cancer Associated Auto Antibodies -... | NCT02066025

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

NCT02066025

Sponsor

Eventus Diagnostics Ltd

Status

Unknown status

Last Update Posted

Feb 19, 2014Estimated

Enrollment

1,425Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Feb 9, 2014

First Submission Date that Met QC Criteria

Feb 17, 2014

First Posted Date

Feb 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2014

Last Update Posted Date

Feb 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

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

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,425Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Galit Yahalom, Ph.D	Contact	+972546922422		galit@eventusdx.com

Name	Affiliation	Role
Galit Yahalom, Ph.D	Eventus Dx	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
"Carmel" Medical Center		Haifa		34362	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24324350	Result	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases