Blood Test for Breast Cancer Associated Auto Antibodies
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 22, 2011
November 1, 2011
April 27, 2011
November 20, 2011
Conditions
Keywords
Study Arms (1)
Suspected Breast cancer subjects
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eventus Diagnostics
Ora, Jerusalem, 90880, Israel
Biospecimen
serum plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanir Allweis, MD
Kaplan Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2011
First Posted
April 28, 2011
Study Start
September 1, 2011
Study Completion
September 1, 2012
Last Updated
November 22, 2011
Record last verified: 2011-11