Blood Test for Breast Cancer Associated Auto Antibodies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01343849
Recruitment Status : Unknown
Verified November 2011 by Eventus Diagnostics Ltd.
Recruitment status was:  Recruiting
First Posted : April 28, 2011
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):
Eventus Diagnostics Ltd

Brief Summary:

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 or disease
Breast Cancer

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Test for Breast Cancer Associated Auto Antibodies
Study Start Date : September 2011
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Suspected Breast cancer subjects

Biospecimen Retention:   Samples With DNA
serum plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01343849

Contact: Tanir Allweis, MD 972-8-9442295
Contact: Nadia Sinai 972-2-6507939

Eventus Diagnostics Recruiting
Ora, Jerusalem, Israel, 90880
Contact: Galit Yahalom, Ph.D.    972-546-922422   
Contact: Nadia Sinai    972-2-6507939   
Principal Investigator: Tanir Allweis, MD         
Sponsors and Collaborators
Eventus Diagnostics Ltd
Principal Investigator: Tanir Allweis, MD Kaplan Medical Center

Responsible Party: Eventus Diagnostics Ltd Identifier: NCT01343849     History of Changes
Other Study ID Numbers: EventusDx_breast_2011ver2
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Eventus Diagnostics Ltd:
breast cancer
auto antibodies

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