Blood Test for Breast Cancer Associated Auto Antibodies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Eventus Diagnostics Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Eventus Diagnostics Ltd
ClinicalTrials.gov Identifier:
NCT01343849
First received: April 27, 2011
Last updated: November 20, 2011
Last verified: November 2011
  Purpose

Intend of use: A blood test for Cancer Associated Auto Antibodies (CAAA) aimed for better diagnostic management of suspected subjects with breast pathology

Study Description: Blood is collected form patients and serum is tested for the presence of CAAA on experimental test kit.

Objectives: To assess the effectiveness of the CAAA test.

Patient Population: The study population will include any women with suspected breast mass detected by any conventional method, scheduled for biopsy, which will result with a pathological verification of the suspected mass.

Target Population: The target population will be any women with suspected breast mass detected by any conventional method, that today, is scheduled for biopsy.

Structure: Subjects that will be enrolled for the study will be checked for the presence of CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the physicians in the participating centers.

Sample Size: Total of 1000 samples, of which 620 samples will ensure at least 124 true positive breast cancer subjects verified by biopsy, and 124 true negative breast cancer subjects verified by biopsy. Additional 400 samples will be used for calibrations and training sets.(Multi center study, statistical rationale provided below).

Primary Effectiveness Variables: The effectiveness of the test will be defined by the specificity of the test conditionally that the sensitivity is not lower than a pre-defined level of 95%.

Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%.

Study Sponsor: Eventus Diagnostics Ltd.

Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical trials. All data will be stored in a protected internet-based database, and any changes of the data will be traced and recorded.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Test for Breast Cancer Associated Auto Antibodies

Resource links provided by NLM:


Further study details as provided by Eventus Diagnostics Ltd:

Biospecimen Retention:   Samples With DNA

serum plasma


Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Groups/Cohorts
Suspected Breast cancer subjects

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The study population includes all women that are scheduled for a pathological or cytological confirmation either by any kind of biopsy or cytology, prior to any anti-cancer treatment. The clinical suspicion includes one of the following: positive mammography/US/MRI, and suspected physical check. Final verification ("true positive" or "true negative") will be done in relation to pathology/cytology only.

Criteria

Inclusion Criteria:

  • Female subjects 18 years or over.
  • Subjects suspected of breast cancer. The clinical suspicion will include one of the following: positive mammography, ultrasound (US), magnetic resonance imaging (MRI), suspected physical exam. Final analysis will be done in relation to pathology only.
  • Subjects scheduled biopsy/surgery

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343849

Contacts
Contact: Tanir Allweis, MD 972-8-9442295 taniral@clalit.org.il
Contact: Nadia Sinai 972-2-6507939 nadia@eventusdx.com

Locations
Israel
Eventus Diagnostics Recruiting
Ora, Jerusalem, Israel, 90880
Contact: Galit Yahalom, Ph.D.    972-546-922422    galit@eventusdx.com   
Contact: Nadia Sinai    972-2-6507939    nadia@eventusdx.com   
Principal Investigator: Tanir Allweis, MD         
Sponsors and Collaborators
Eventus Diagnostics Ltd
Investigators
Principal Investigator: Tanir Allweis, MD Kaplan Medical Center
  More Information

No publications provided

Responsible Party: Eventus Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT01343849     History of Changes
Other Study ID Numbers: EventusDx_breast_2011ver2
Study First Received: April 27, 2011
Last Updated: November 20, 2011
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by Eventus Diagnostics Ltd:
breast cancer
auto antibodies

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014